Spacelabs Healthcare Inc: Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

Recall number

Z-1542-2015

Recalling firm

Spacelabs Healthcare Inc

Product

Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

Status

Terminated

Initiated

2015-04-17

Posted

2015-04-28

Terminated

2015-11-13

Reason

Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.

Root cause

Software design

Action

Spacelabs Healthcare sent an Urgent - Medical Device Correction letter, dated 17 April 2015, to the US consignees via priority mail. On 4/24/2015, the firm will send the Urgent - Medical Device Correction letter (translated as necessary) via email to international subsidiaries and distributor of record. The Identified the affected product, problem and actions to be taken. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M are affected. Ultraview SL Command Modules originally shipped with Masimo SpO2 are NOT affected. Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to correct all of your facility's affected Command Modules at no cost. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support

Quantity

1999 units total (1932 in the US and 67 international)

Distribution

Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.

Lot, serial or model codes

SERIAL NUMBERS IN THE US:  1496-000473, 1496-000590, 1496-001126, 1496-001189, 1496-001214, 1496-001299, 1496-001300, 1496-001301, 1496-001302, 1496-001303, 1496-001304, 1496-001305, 1496-001306, 1496-001307, 1496-001309, 1496-001328, 1496-001329, 1496-001330, 1496-001332, 1496-001333, 1496-001335, 1496-001336, 1496-001337, 1496-001712, 1496-001713, 1496-001714, 1496-002442, 1496-002568, 1496-002691, 1496-002743, 1496-002832, 1496-002833, 1496-002834, 1496-002836, 1496-002837, 1496-002838, 1496-002839, 1496-002840, 1496-002841, 1496-002917, 1496-002918, 1496-002919, 1496-002920, 1496-002998, 1496-002999, 1496-003000, 1496-003001, 1496-003002, 1496-003003, 1496-003005, 1496-003006, 1496-003007, 1496-003021, 1496-003022, 1496-003025, 1496-003035, 1496-003036, 1496-003037, 1496-003042, 1496-003043, 1496-003044, 1496-003046, 1496-003049, 1496-003051, 1496-003055, 1496-003158, 1496-003161, 1496-003162, 1496-003163, 1496-003164, 1496-003179, 1496-003187, 1496-003190, 1496-003191, 1496-003192, 1496-003193, 1496-003210, 1496-003528, 1496-003602, 1496-003796, 1496-003797, 1496-003819, 1496-004075, 1496-004081, 1496-004082, 1496-004088, 1496-004095, 1496-004098, 1496-004100, 1496-004103, 1496-004104, 1496-004110, 1496-004174, 1496-004175, 1496-004222, 1496-004302, 1496-004382, 1496-004385, 1496-004386, 1496-004387, 1496-004390, 1496-004392, 1496-004394, 1496-004622, 1496-004667, 1496-004674, 1496-004675, 1496-004676, 1496-004737, 1496-004762, 1496-004805, 1496-004806, 1496-004886, 1496-004892, 1496-004951, 1496-004980, 1496-005204, 1496-005291, 1496-005292, 1496-005293, 1496-005294, 1496-005342, 1496-005343, 1496-005358, 1496-005359, 1496-005371, 1496-005374, 1496-005380, 1496-005611, 1496-005779, 1496-005780, 1496-005781, 1496-005782, 1496-005785, 1496-005786, 1496-005787, 1496-005889, 1496-005890, 1496-005891, 1496-005892, 1496-005894, 1496-005896, 1496-005897, 1496-005898, 1496-005899, 1496-005900, 1496-005901, 1496-005903, 1496-005904, 1496-005905, 1496-006038, 1496-006058, 1496-006078, 1496-006089, 1496-006108, 1496-006109, 1496-006110, 1496-006140, 1496-006141, 1496-006142, 1496-006143, 1496-006144, 1496-006145, 1496-006249, 1496-006250, 1496-006251, 1496-006252, 1496-006253, 1496-006254, 1496-006255, 1496-006256, 1496-006257, 1496-006258, 1496-006259, 1496-006260, 1496-006261, 1496-006262, 1496-006266, 1496-006267, 1496-006268, 1496-006269, 1496-006270, 1496-006271, 1496-006272, 1496-006273, 1496-006327, 1496-006328, 1496-006329, 1496-006330, 1496-006331, 1496-006332, 1496-006333, 1496-006334, 1496-006336, 1496-006337, 1496-006338, 1496-006341, 1496-006342, 1496-006343, 1496-006457, 1496-006472, 1496-006523, 1496-006544, 1496-006593, 1496-006594, 1496-006595, 1496-006596, 1496-006597, 1496-006877, 1496-006972, 1496-006973, 1496-006981, 1496-006982, 1496-006983, 1496-006984, 1496-006985, 1496-006986, 1496-006994, 1496-006995, 1496-006996, 1496-006997, 1496-006998, 1496-007132, 1496-007137, 1496-007318, 1496-007319, 1496-007320, 1496-007321, 1496-007322, 1496-007323, 1496-007324, 1496-007325, 1496-007326, 1496-007327, 1496-007328, 1496-007329, 1496-007330, 1496-007331, 1496-007332, 1496-007333, 1496-007334, 1496-007335, 1496-007336, 1496-007337, 1496-007338, 1496-007339, 1496-007340, 1496-007376, 1496-007587, 1496-007589, 1496-007590, 1496-007593, 1496-007594, 1496-007595, 1496-007596, 1496-007631, 1496-007647, 1496-007650, 1496-007651, 1496-007652, 1496-007653, 1496-007654, 1496-007655, 1496-007656, 1496-007657, 1496-007658, 1496-007745, 1496-007750, 1496-007753, 1496-007755, 1496-007756, 1496-007757, 1496-007969, 1496-007970, 1496-008009, 1496-008010, 1496-008011, 1496-008012, 1496-008013, 1496-008014, 1496-008015, 1496-008046, 1496-008047, 1496-008048, 1496-008161, 1496-008162, 1496-008163, 1496-008250, 1496-008319, 1496-008383, 1496-008450, 1496-008451, 1496-008452, 1496-008453, 1496-008454, 1496-008455, 1496-008456, 1496-008580, 1496-008584, 1496-008587, 1496-008873, 1496-009392, 1496-009393, 1496-009394, 1496-009395, 1496-009396, 1496-009397, 1496-009398, 1496-009399, 1496-009400, 1496-009401, 1496-009524, 1496-009584, 1496-009585, 1496-009586, 1496-009587, 1496-009588, 1496-009589, 1496-009590, 1496-009591, 1496-009592, 1496-009593, 1496-009594, 1496-009595, 1496-009596, 1496-009597, 1496-009598, 1496-009599, 1496-009600, 1496-009601, 1496-009602, 1496-009603, 1496-009604, 1496-009605, 1496-009606, 1496-009607, 1496-009608, 1496-009715, 1496-009733, 1496-009734, 1496-009737, 1496-009738, 1496-009760, 1496-009761, 1496-009762, 1496-009763, 1496-009764, 1496-009765, 1496-009766, 1496-009767, 1496-009778, 1496-009779, 1496-009781, 1496-009782, 1496-009783, 1496-009784, 1496-009785, 1496-009786, 1496-009787, 1496-009788, 1496-009856, 1496-009861, 1496-009862, 1496-009867, 1496-009874, 1496-009877, 1496-009879, 1496-009963, 1496-009968, 1496-010008, 1496-010009, 1496-010010, 1496-010011, 1496-010012, 1496-010013, 1496-010017, 1496-010018, 1496-010019, 1496-010068, 1496-010113, 1496-010252, 1496-010260, 1496-010273, 1496-010278, 1496-010287, 1496-010288, 1496-010290, 1496-010291, 1496-010292, 1496-010293, 1496-010294, 1496-010295, 1496-010296, 1496-010297, 1496-010298, 1496-010299, 1496-010300, 1496-010301, 1496-010302, 1496-010469, 1496-010470, 1496-010471, 1496-010472, 1496-010473, 1496-010474, 1496-010475, 1496-010476, 1496-010477, 1496-010478, 1496-010523, 1496-010524, 1496-010526, 1496-010527, 1496-010528, 1496-010529, 1496-010530, 1496-010531, 1496-010532, 1496-010533, 1496-010534, 1496-010535, 1496-010537, 1496-010539, 1496-010540, 1496-010541, 1496-010542, 1496-010543, 1496-010545, 1496-010546, 1496-010547, 1496-010548, 1496-010550, 1496-010691, 1496-010692, 1496-010809, 1496-010830, 1496-010927, 1496-010933, 1496-010952, 1496-010959, 1496-010960, 1496-011059, 1496-011060, 1496-011069, 1496-011070, 1496-011210, 1496-011211, 1496-011246, 1496-011247, 1496-011248, 1496-011249, 1496-011250, 1496-011252, 1496-011253, 1496-011256, 1496-011259, 1496-011306, 1496-011307, 1496-011308, 1496-011309, 1496-011310, 1496-011311, 1496-011312, 1496-011313, 1496-011314, 1496-011315, 1496-011317, 1496-011552, 1496-011555, 1496-011716, 1496-011894, 1496-011902, 1496-011908, 1496-011923, 1496-012278, 1496-012280, 1496-012307, 1496-012320, 1496-012343, 1496-012426, 1496-012429, 1496-012431, 1496-012432, 1496-012434, 1496-012470, 1496-012478, 1496-012495, 1496-012496, 1496-012497, 1496-012615, 1496-012616, 1496-012617, 1496-012618, 1496-012620, 1496-012621, 1496-012623, 1496-012624, 1496-012625, 1496-012626, 1496-012628, 1496-012629, 1496-012630, 1496-012631, 1496-012632, 1496-012633, 1496-012634, 1496-012635, 1496-012636, 1496-012637, 1496-012638, 1496-012639, 1496-012640, 1496-012642, 1496-013314, 1496-013383, 1496-013563, 1496-013564, 1496-013565, 1496-013566, 1496-013567, 1496-013568, 1496-013569, 1496-013570, 1496-013571, 1496-013572, 1496-013573, 1496-013574, 1496-013575, 1496-013578, 1496-013579, 1496-013580, 1496-013583, 1496-013584, 1496-013585, 1496-013586, 1496-013587, 1496-013588, 1496-013590, 1496-013591, 1496-013683, 1496-013705, 1496-013706, 1496-013709, 1496-013710, 1496-013711, 1496-013712, 1496-013713, 1496-013732, 1496-013733, 1496-013734, 1496-013735, 1496-013998, 1496-013999, 1496-014000, 1496-014001, 1496-014002, 1496-014003, 1496-014004, 1496-014005, 1496-014006, 1496-014007, 1496-014008, 1496-014009, 1496-014010, 1496-014011, 1496-014012, 1496-014015, 1496-014016, 1496-014017, 1496-014018, 1496-014019, 1496-014020, 1496-014065, 1496-014135, 1496-014136, 1496-014172, 1496-014173, 1496-014174, 1496-014175, 1496-014177, 1496-014178, 1496-014179, 1496-014180, 1496-014181, 1496-014339, 1496-014340, 1496-014341, 1496-014342, 1496-014343, 1496-014344, 1496-014345, 1496-014346, 1496-014348, 1496-014349, 1496-014350, 1496-014351, 1496-014352, 1496-014353, 1496-014354, 1496-014355, 1496-014356, 1496-014357, 1496-014358, 1496-014359, 1496-014360, 1496-014361, 1496-014362, 1496-014445, 1496-014446, 1496-014447, 1496-014448, 1496-014449, 1496-014451, 1496-014462, 1496-014484, 1496-014485, 1496-014486, 1496-014487, 1496-014506, 1496-014517, 1496-014536, 1496-014537, 1496-014542, 1496-014552, 1496-014554, 1496-014555, 1496-014835, 1496-014964, 1496-014965, 1496-014966, 1496-014967, 1496-014968, 1496-014970, 1496-014971, 1496-014972, 1496-014973, 1496-014974, 1496-014975, 1496-014976, 1496-014978, 1496-014979, 1496-014980, 1496-014982, 1496-014983, 1496-014984, 1496-014985, 1496-014986, 1496-014988, 1496-015059, 1496-015082, 1496-015084, 1496-015181, 1496-015183, 1496-015184, 1496-015185, 1496-015217, 1496-015218, 1496-015219, 1496-015220, 1496-015221, 1496-015222, 1496-015223, 1496-015224, 1496-015225, 1496-015226, 1496-015227, 1496-015228, 1496-015229, 1496-015230, 1496-015231, 1496-015232, 1496-015233, 1496-015234, 1496-015235, 1496-015236, 1496-015237, 1496-015257, 1496-015258, 1496-015259, 1496-015260, 1496-015261, 1496-015263, 1496-015264, 1496-015265, 1496-015266, 1496-015267, 1496-015268, 1496-015269, 1496-015270, 1496-015272, 1496-015273, 1496-015274, 1496-015276, 1496-015277, 1496-015278, 1496-015279, 1496-015280, 1496-015281, 1496-015282, 1496-015283, 1496-015284, 1496-015285, 1496-015286, 1496-015288, 1496-015289, 1496-015290, 1496-015292, 1496-015293, 1496-015294, 1496-015295, 1496-015296, 1496-015297, 1496-015298, 1496-015299, 1496-015300, 1496-015301, 1496-015302, 1496-015303, 1496-015304, 1496-015312, 1496-016051, 1496-016052, 1496-016053, 1496-016056, 1496-016249, 1496-016250, 1496-016499, 1496-016509, 1496-016526, 1496-016527, 1496-016530, 1496-016804, 1496-016870, 1496-016938, 1496-016946, 1496-016956, 1496-016959, 1496-016960, 1496-016965, 1496-016966, 1496-016967, 1496-016968, 1496-016969, 1496-016970, 1496-016972, 1496-016974, 1496-016975, 1496-016977, 1496-016979, 1496-016980, 1496-016981, 1496-016983, 1496-016984, 1496-016985, 1496-016986, 1496-016987, 1496-017379, 1496-017408, 1496-017409, 1496-017410, 1496-017411, 1496-017412, 1496-017413, 1496-017414, 1496-017415, 1496-017416, 1496-017417, 1496-017418, 1496-017419, 1496-017420, 1496-017421, 1496-017422, 1496-017423, 1496-017424, 1496-017425, 1496-017426, 1496-017427, 1496-017428, 1496-017429, 1496-017430, 1496-017431, 1496-017432, 1496-017433, 1496-017434, 1496-017435, 1496-017436, 1496-017437, 1496-017438, 1496-017439, 1496-017440, 1496-017441, 1496-017442, 1496-017443, 1496-017444, 1496-017445, 1496-017446, 1496-017447, 1496-017448, 1496-017449, 1496-017491, 1496-017492, 1496-017493, 1496-017494, 1496-017547, 1496-017548, 1496-017549, 1496-017550, 1496-017551, 1496-017552, 1496-017555, 1496-017556, 1496-017557, 1496-017558, 1496-017559, 1496-017560, 1496-017561, 1496-017562, 1496-017563, 1496-017564, 1496-017599, 1496-017659, 1496-017660, 1496-017661, 1496-017663, 1496-017664, 1496-017665, 1496-017666, 1496-017667, 1496-017882, 1496-017883, 1496-017884, 1496-017885, 1496-017886, 1496-017888, 1496-017889, 1496-017890, 1496-017891, 1496-017892, 1496-017893, 1496-017895, 1496-017896, 1496-017897, 1496-017898, 1496-017899, 1496-017900, 1496-017901, 1496-017902, 1496-017903, 1496-017904, 1496-017905, 1496-018140, 1496-018277, 1496-018498, 1496-018499, 1496-018501, 1496-018506, 1496-018511, 1496-018512, 1496-018513, 1496-018657, 1496-018658, 1496-018659, 1496-018660, 1496-018661, 1496-018662, 1496-018663, 1496-018664, 1496-018665, 1496-018666, 1496-018667, 1496-018668, 1496-018669, 1496-018670, 1496-018671, 1496-018672, 1496-018673, 1496-018674, 1496-018675, 1496-018676, 1496-018715, 1496-018716, 1496-018717, 1496-018719, 1496-018720, 1496-018721, 1496-018722, 1496-019217, 1496-019221, 1496-019491, 1496-019492, 1496-019584, 1496-020047, 1496-020049, 1496-020073, 1496-020074, 1496-020075, 1496-020076, 1496-020077, 1496-020078, 1496-020079, 1496-020080, 1496-020081, 1496-020082, 1496-020083, 1496-020084, 1496-020085, 1496-020086, 1496-020087, 1496-020088, 1496-020089, 1496-020090, 1496-020091, 1496-020178, 1496-020278, 1496-020279, 1496-020280, 1496-020281, 1496-020282, 1496-020283, 1496-020284, 1496-020293, 1496-020294, 1496-020295, 1496-020296, 1496-020297, 1496-020298, 1496-020308, 1496-020311, 1496-020348, 1496-020349, 1496-020350, 1496-020807, 1496-021310, 1496-021443, 1496-021457, 1496-021458, 1496-021459, 1496-021460, 1496-021461, 1496-021462, 1496-021463, 1496-021464, 1496-021465, 1496-021466, 1496-021467, 1496-021468, 1496-021469, 1496-021470, 1496-021471, 1496-021472, 1496-021473, 1496-021474, 1496-021475, 1496-021476, 1496-021477, 1496-021478, 1496-021479, 1496-021480, 1496-021481, 1496-021482, 1496-021483, 1496-021484, 1496-021485, 1496-021486, 1496-021487, 1496-021488, 1496-021504, 1496-021505, 1496-021506, 1496-021507, 1496-021508, 1496-021509, 1496-021510, 1496-021511, 1496-021512, 1496-021513, 1496-021520, 1496-021677, 1496-021715, 1496-021723, 1496-021743, 1496-021758, 1496-023510, 1496-023558, 1496-023559, 1496-023560, 1496-023561, 1496-023563, 1496-023564, 1496-023565, 1496-023566, 1496-023567, 1496-023858, 1496-024742, 1496-024804, 1496-024832, 1496-025119, 1496-025120, 1496-025121, 1496-025122, 1496-025123, 1496-025124, 1496-025126, 1496-025197, 1496-025199, 1496-025202, 1496-025203, 1496-025204, 1496-025205, 1496-025206, 1496-025207, 1496-025208, 1496-025209, 1496-025234, 1496-025235, 1496-025236, 1496-025237, 1496-025238, 1496-025506, 1496-025512, 1496-025513, 1496-025514, 1496-025515, 1496-025516, 1496-025517, 1496-025518, 1496-025618, 1496-025619, 1496-025654, 1496-025657, 1496-025658, 1496-025660, 1496-025661, 1496-025662, 1496-025663, 1496-025664, 1496-025665, 1496-025666, 1496-025667, 1496-025668, 1496-025669, 1496-025670, 1496-025671, 1496-025672, 1496-025673, 1496-025674, 1496-025675, 1496-025676, 1496-025677, 1496-025678, 1496-025679, 1496-025680, 1496-025681, 1496-025682, 1496-025683, 1496-025684, 1496-025685, 1496-025686, 1496-025687, 1496-025688, 1496-025689, 1496-025690, 1496-025691, 1496-025692, 1496-025693, 1496-025694, 1496-025695, 1496-025696, 1496-025697, 1496-025698, 1496-025699, 1496-025701, 1496-025702, 1496-025704, 1496-025705, 1496-025706, 1496-025707, 1496-025708, 1496-025709, 1496-025710, 1496-025769, 1496-025770, 1496-025771, 1496-025941, 1496-025942, 1496-026067, 1496-026068, 1496-026070, 1496-026072, 1496-026075, 1496-026076, 1496-026077, 1496-026078, 1496-026079, 1496-026080, 1496-026081, 1496-026082, 1496-026083, 1496-026309, 1496-026310, 1496-026311, 1496-026362, 1496-026363, 1496-026364, 1496-026365, 1496-026366, 1496-026367, 1496-026368, 1496-026369, 1496-026370, 1496-026373, 1496-026374, 1496-026429, 1496-027022, 1496-027070, 1496-027071, 1496-027103, 1496-027111, 1496-027112, 1496-027409, 1496-027410, 1496-027411, 1496-027412, 1496-027413, 1496-027414, 1496-027415, 1496-027416, 1496-027472, 1496-027578, 1496-027579, 1496-027580, 1496-027581, 1496-028419, 1496-028442, 1496-028459, 1496-028461, 1496-028462, 1496-028465, 1496-028466, 1496-028467, 1496-028665, 1496-028710, 1496-028711, 1496-028822, 1496-028824, 1496-028825, 1496-028826, 1496-028827, 1496-028829, 1496-028831, 1496-028832, 1496-028833, 1496-028834, 1496-028836, 1496-028837, 1496-028838, 1496-028839, 1496-028840, 1496-028841, 1496-028842, 1496-028843, 1496-028844, 1496-028845, 1496-028846, 1496-028847, 1496-028848, 1496-028850, 1496-028851, 1496-028852, 1496-028853, 1496-028854, 1496-028855, 1496-029028, 1496-029051, 1496-029575, 1496-029595, 1496-029723, 1496-029724, 1496-029725, 1496-029726, 1496-029727, 1496-029728, 1496-029985, 1496-030010, 1496-030932, 1496-030933, 1496-030934, 1496-031144, 1496-031145, 1496-031190, 1496-031784, 1496-031785, 1496-031786, 1496-031787, 1496-031788, 1496-031789, 1496-031790, 1496-031791, 1496-031792, 1496-031793, 1496-031794, 1496-031795, 1496-031796, 1496-031798, 1496-031799, 1496-031800, 1496-031802, 1496-031803, 1496-031804, 1496-031805, 1496-031806, 1496-031807, 1496-031809, 1496-031810, 1496-031811, 1496-031812, 1496-031814, 1496-031815, 1496-031816, 1496-032015, 1496-032016, 1496-032375, 1496-032414, 1496-032418, 1496-032660, 1496-032661, 1496-032662, 1496-032663, 1496-032721, 1496-032792, 1496-032793, 1496-033426, 1496-033785, 1496-034033, 1496-034251, 1496-034259, 1496-034260, 1496-034261, 1496-034262, 1496-034263, 1496-034264, 1496-034265, 1496-034266, 1496-034267, 1496-034268, 1496-034540, 1496-034553, 1496-034560, 1496-034583, 1496-034711, 1496-034712, 1496-034713, 1496-034925, 1496-035276, 1496-035296, 1496-035417, 1496-036293, 1496-036294, 1496-036295, 1496-036424, 1496-037006, 1496-037007, 1496-037008, 1496-037009, 1496-037010, 1496-037011, 1496-037012, 1496-037013, 1496-037014, 1496-037015, 1496-037157, 1496-037158, 1496-037633, 1496-037684, 1496-037685, 1496-037686, 1496-037687, 1496-037688, 1496-037689, 1496-045292, 1496-045293, 1496-045294, 1496-045295, 1496-045296, 1496-045297, 1496-045310, 1496-045626, 1496-045627, 1496-045628, 1496-045909, 1496-045911, 1496-045913, 1496-045914, 1496-045915, 1496-045916, 1496-046010, 1496-046011, 1496-046012, 1496-046013, 1496-046761, 1496-046763, 1496-046764, 1496-046765, 1496-046766, 1496-046767, 1496-046768, 1496-046769, 1496-046770, 1496-046771, 1496-046772, 1496-046773, 1496-046774, 1496-046775, 1496-046776, 1496-046777, 1496-046779, 1496-046780, 1496-048077, 1496-048078, 1496-048079, 1496-048081, 1496-048082, 1496-048083, 1496-048175, 1496-048176, 1496-049930, 1496-100886, 1496-100887, 1496-100888, 1496-100889, 1496-100890, 1496-100891, 1496-100892, 1496-100893, 1496-100894, 1496-100895, 1496-100896, 1496-100897, 1496-100898, 1496-100899, 1496-101134, 1496-101140, 1496-101141, 1496-101148, 1496-101151, 1496-101189, 1496-101190, 1496-101191, 1496-101192, 1496-101193, 1496-101194, 1496-101195, 1496-101196, 1496-101197, 1496-101198, 1496-101199, 1496-101200, 1496-101202, 1496-101203, 1496-101204, 1496-101205, 1496-102018, 1496-102019, 1496-102020, 1496-102021, 1496-102022, 1496-102023, 1496-102024, 1496-102025, 1496-102026, 1496-102027, 1496-102045, 1496-102054, 1496-102055, 1496-102056, 1496-102057, 1496-102058, 1496-102158, 1496-102159, 1496-102160, 1496-102161, 1496-102163, 1496-102164, 1496-102165, 1496-102216, 1496-102549, 1496-102655, 1496-102656, 1496-102657, 1496-102658, 1496-102659, 1496-102787, 1496-102788, 1496-102789, 1496-102790, 1496-102791, 1496-103435, 1496-103436, 1496-103437, 1496-103438, 1496-103439, 1496-103440, 1496-103441, 1496-103610, 1496-103611, 1496-103639, 1496-103710, 1496-103711, 1496-103712, 1496-103713, 1496-103714, 1496-103715, 1496-103716, 1496-103717, 1496-103718, 1496-103719, 1496-104419, 1496-104424, 1496-104425, 1496-104426, 1496-104427, 1496-104428, 1496-104547, 1496-104548, 1496-104549, 1496-104550, 1496-104551, 1496-104552, 1496-104553, 1496-104554, 1496-104555, 1496-104556, 1496-104557, 1496-104558, 1496-104559, 1496-104560, 1496-104561, 1496-104563, 1496-104564, 1496-104565, 1496-104566, 1496-104567, 1496-104568, 1496-105356, 1496-105357, 1496-105358, 1496-105360, 1496-105373, 1496-105382, 1496-105383, 1496-105688, 1496-105747, 1496-105748, 1496-105749, 1496-105750, 1496-105751, 1496-105752, 1496-105753, 1496-105754, 1496-105755, 1496-105756, 1496-105757, 1496-105758, 1496-105759, 1496-105760, 1496-105761, 1496-105762, 1496-105763, 1496-105764, 1496-105766, 1496-105767, 1496-105768, 1496-105769, 1496-105770, 1496-105771, 1496-105772, 1496-105773, 1496-105774, 1496-105775, 1496-105776, 1496-105777, 1496-105778, 1496-105779, 1496-105780, 1496-105781, 1496-105782, 1496-105783, 1496-105784, 1496-105785, 1496-105786, 1496-105787, 1496-105788, 1496-105789, 1496-105790, 1496-105791, 1496-105792, 1496-105793, 1496-105794, 1496-105795, 1496-105796, 1496-105797, 1496-105798, 1496-105799, 1496-105800, 1496-105801, 1496-105802, 1496-105803, 1496-105804, 1496-105805, 1496-105806, 1496-105807, 1496-105808, 1496-105809, 1496-105810, 1496-105811, 1496-105812, 1496-105813, 1496-105814, 1496-105815, 1496-105816, 1496-105817, 1496-105818, 1496-105819, 1496-105821, 1496-105822, 1496-105823, 1496-105824, 1496-105825, 1496-105826, 1496-105827, 1496-105828, 1496-105829, 1496-105830, 1496-105831, 1496-105832, 1496-105833, 1496-105834, 1496-105835, 1496-105836, 1496-105837, 1496-105838, 1496-105839, 1496-105840, 1496-105841, 1496-105842, 1496-105843, 1496-105844, 1496-105845, 1496-105846, 1496-105847, 1496-105848, 1496-105849, 1496-105850, 1496-105851, 1496-105852, 1496-105853, 1496-105854, 1496-105855, 1496-105856, 1496-105857, 1496-105858, 1496-105859, 1496-105860, 1496-105861, 1496-105862, 1496-105863, 1496-105864, 1496-105865, 1496-105866, 1496-105867, 1496-105868, 1496-105869, 1496-105870, 1496-105871, 1496-105872, 1496-105873, 1496-105874, 1496-105875, 1496-105876, 1496-105877, 1496-105878, 1496-105879, 1496-105880, 1496-105881, 1496-105882, 1496-105883, 1496-105884, 1496-105885, 1496-105886, 1496-105887, 1496-105888, 1496-105889, 1496-105890, 1496-105891, 1496-105892, 1496-105893, 1496-105894, 1496-105895, 1496-105896, 1496-105897, 1496-105898, 1496-105899, 1496-105900, 1496-105901, 1496-105902, 1496-105903, 1496-105904, 1496-105905, 1496-105906, 1496-105907, 1496-105908, 1496-105909, 1496-105910, 1496-105911, 1496-105912, 1496-105913, 1496-105914, 1496-105915, 1496-105916, 1496-105917, 1496-105918, 1496-105919, 1496-105920, 1496-105921, 1496-105922, 1496-105923, 1496-105924, 1496-105925, 1496-105926, 1496-105927, 1496-105928, 1496-105929, 1496-105930, 1496-105931, 1496-105932, 1496-105933, 1496-105934, 1496-105935, 1496-105936, 1496-105937, 1496-105938, 1496-105939, 1496-105940, 1496-105941, 1496-105942, 1496-105943, 1496-105944, 1496-105945, 1496-105946, 1496-105947, 1496-105948, 1496-105949, 1496-105950, 1496-105951, 1496-105952, 1496-105953, 1496-105954, 1496-105955, 1496-105956, 1496-105957, 1496-105958, 1496-105959, 1496-105960, 1496-105961, 1496-105962, 1496-105963, 1496-105964, 1496-105965, 1496-105966, 1496-105967, 1496-105968, 1496-105969, 1496-105970, 1496-105971, 1496-105972, 1496-105973, 1496-105974, 1496-105975, 1496-105976, 1496-105977, 1496-105978, 1496-105979, 1496-105980, 1496-105981, 1496-105982, 1496-105983, 1496-105984, 1496-105985, 1496-105986, 1496-105987, 1496-105988, 1496-105989, 1496-105990, 1496-105991, 1496-105992, 1496-105993, 1496-105994, 1496-105995, 1496-105996, 1496-105997, 1496-105998, 1496-105999, 1496-106000, 1496-106001, 1496-106002, 1496-106003, 1496-106004, 1496-106005, 1496-106006, 1496-106007, 1496-106008, 1496-106009, 1496-106010, 1496-106011, 1496-106012, 1496-106013, 1496-106014, 1496-106015, 1496-106016, 1496-106017, 1496-106018, 1496-106019, 1496-106020, 1496-106021, 1496-106022, 1496-106023, 1496-106024, 1496-106025, 1496-106026, 1496-106027, 1496-106028, 1496-106029, 1496-106030, 1496-106031, 1496-106032, 1496-106033, 1496-106034, 1496-106035, 1496-106036, 1496-106037, 1496-106038, 1496-106039, 1496-106040, 1496-106041, 1496-106042, 1496-106043, 1496-106044, 1496-106045, 1496-106046, 1496-106047, 1496-106048, 1496-106049, 1496-106050, 1496-106051, 1496-106052, 1496-106053, 1496-106054, 1496-106055, 1496-106056, 1496-106057, 1496-106058, 1496-106059, 1496-106060, 1496-106061, 1496-106062, 1496-106063, 1496-106064, 1496-106065, 1496-106066, 1496-106067, 1496-106068, 1496-106069, 1496-106070, 1496-106071, 1496-106072, 1496-106073, 1496-106074, 1496-106286, 1496-106287, 1496-106288, 1496-106289, 1496-106290, 1496-106291, 1496-106292, 1496-106293, 1496-106294, 1496-106295, 1496-106296, 1496-106297, 1496-106298, 1496-106299, 1496-106300, 1496-106301, 1496-106302, 1496-106303, 1496-106304, 1496-106305, 1496-106306, 1496-106307, 1496-106308, 1496-106309, 1496-106310, 1496-106311, 1496-106458, 1496-106459, 1496-106460, 1496-106461, 1496-106462, 1496-106463, 1496-106464, 1496-106465, 1496-106466, 1496-106467, 1496-106468, 1496-106469, 1496-106470, 1496-106471, 1496-106472, 1496-106498, 1496-106500, 1496-106501, 1496-106502, 1496-106503, 1496-106504, 1496-106505, 1496-106506, 1496-106507, 1496-106508, 1496-106509, 1496-106510, 1496-106511, 1496-106512, 1496-106513, 1496-106514, 1496-106515, 1496-106516, 1496-106517, 1496-106518, 1496-106519, 1496-106520, 1496-106521, 1496-106522, 1496-106523, 1496-106524, 1496-106525, 1496-106526, 1496-106527, 1496-106528, 1496-106529, 1496-107878, 1496-107882, 1496-107884, 1496-107903, 1496-107904, 1496-107905, 1496-107906, 1496-109257, 1496-109258, 1496-109259, 1496-109260, 1496-109261, 1496-109263, 1496-109264, 1496-109265, 1496-109266, 1496-109267, 1496-109298, 1496-109299, 1496-109300, 1496-109301, 1496-109302, 1496-109303, 1496-109304, 1496-109305, 1496-109306, 1496-109322, 1496-109323, 1496-109324, 1496-109325, 1496-112374, 1496-112632, 1496-117845, 1496-120087, 1496-120088, 1496-120089, 1496-120090, 1496-120091, 1496-120605, 1496-120725, 1496-120726, 1496-120727, 1496-120728, 1496-120729, 1496-120730, 1496-120731, 1496-120732, 1496-120733, 1496-120734, 1496-120757, 1496-120758, 1496-120759, 1496-120760, 1496-120761, 1496-120762, 1496-120763, 1496-120764, 1496-120765, 1496-120766, 1496-120767, 1496-120768, 1496-120769, 1496-121121, 1496-121973, 1496-121974, 1496-121975, 1496-121976, 1496-121977, 1496-121978, 1496-121979, 1496-121980, 1496-121981, 1496-121982, 1496-121983, 1496-121984, 1496-121985, 1496-121986, 1496-121987, 1496-121988, 1496-121989, 1496-121990, 1496-121991, and 1496-121992.   **********SERIAL NUMBERS INTERNATIONAL*********************************  1496-001139, 1496-001925, 1496-002364, 1496-002372, 1496-002410, 1496-002411, 1496-002483, 1496-002486, 1496-002501, 1496-002509, 1496-002521, 1496-002542, 1496-002543, 1496-003059, 1496-006322, 1496-006323, 1496-006324, 1496-006702, 1496-009407, 1496-009518, 1496-009550, 1496-009739, 1496-009953, 1496-009979, 1496-010250, 1496-010251, 1496-010257, 1496-010259, 1496-010261, 1496-010779, 1496-011011, 1496-011322, 1496-011553, 1496-011927, 1496-012393, 1496-012715, 1496-012729, 1496-014969, 1496-016724, 1496-017329, 1496-019070, 1496-033510, 1496-038108, 1496-113895, 1496-113896, 1496-113911, 1496-113935, 1496-113936, 1496-113938, 1496-113939, 1496-113940, 1496-113941, 1496-113944, 1496-113945, 1496-113946, 1496-113947, 1496-113948, 1496-113949, 1496-113950, 1496-113951, 1496-113952, 1496-113953, 1496-113954, 1496-113956, 1496-113957, 1496-113958, and 1496-113959.

510(k) numbers

["K103142"]

PMA numbers

not on file

Product code

DSI

Firm FEI

3010157426

Firm city

Snoqualmie

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy