Philips Medical Systems North America Co. Phillips: The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

Recall number

Z-0034-2011

Recalling firm

Philips Medical Systems North America Co. Phillips

Product

The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

Status

Terminated

Initiated

2008-11-21

Posted

2010-10-08

Terminated

2010-10-12

Reason

Potential for Internal Sound Amplifier to malfunction which could delay treatment.

Root cause

Component change control

Action

On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service. The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set. The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 "Adjusting Alarm Tone Volume" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301. Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.

Quantity

424 units in US.

Distribution

Nationwide Distribution

Lot, serial or model codes

Serial numbers are:  4810A03287, 4810A03260, 4810A03261, 4810A03262, 4810A04902, 4810A04906, 4810A04907, 4810A04908, 4810A04909, 4810A04910, 4810A04911, 4810A04912, 4810A05422, 4810A05423, 4810A11902, 4810A03367, 4810A03368, 4810A03369, 4810A03370, 4810A03372, 4810A03231, 4810A03240, 4810A03241, 4810A03242, 4810A03254, 4810A03255, 4810A03256, 4810A03257, 4810A03243, 4810A03244, 4810A03245, 4810A02772, 4810A04096, 4810A04097, 4810A04094, 4810A04095, 4810A04084, 4810A04085, 4810A03710, 4810A03711, 4810A03407, 4810A03408, 4810A03409, 4810A03410, 4810A04494, 4810A03934, 4810A03935, 4810A04768, 4810A04783, 4810A04809, 4810A04810, 4810A03631, 4810A04805, 4810A04598, 4810A11904, 4810A04053, 4810A11873, 4810A05158, 4810A05167, 4810A03078, 4810A03762, 4810A11903, 4810A05378, 4810A04798, 4810A04799, 4810A04800, 4810A04764, 4810A04765, 4810A04801, 4810A04802, 4810A04803, 4810A04804, 4810A04784, 4810A04785, 4810A04786, 4820A10136, 4820A10138, 4820A10139, 4820A10124, 4820A10125, 4820A11906, 4820A11905, 4810A03623, 4810A04796, 4810A04763, 4810A04777, 4810A04778, 4810A04779, 4810A04780, 4810A04781, 4810A09398, 4810A11851, 4810A03643, 4810A04664, 4810A04650, 4810A04651, 4810A04652, 4810A09748, 4810A09749, 4810A04565, 4810A04567, 4810A04568, 4810A05277, 4810A05278, 4810A05280, 4810A05281, 4810A04437, 4810A04438, 4810A05288, 4810A05289, 4810A05290, 4810A05291, 4810A05292, 4810A05293, 4810A05282, 4810A05283, 4810A05284, 4810A05285, 4810A05286, 4810A05287, 4810A04573, 4810A04574, 4810A04663, 4810A02713, 4810A02714, 4810A02715, 4810A02716, 4810A02762, 4810A02770, 4810A05397, 4810A05398, 4810A05399, 4810A05400, 4810A11881, 4810A05424, 4810A09648, 4810A09649, 4810A09650, 4810A09651, 4810A03699, 4810A03700, 4810A03702, 4810A03703, 4810A02941, 4810A02942, 4810A02943, 4810A02944, 4810A02945, 4810A02946, 4810A02947, 4810A02948, 4810A09687, 4810A11858, 4810A11877, 4810A02976, 4810A02962, 4810A02963, 4810A02964, 4810A02965, 4810A02966, 4810A02922, 4810A05425, 4810A05413, 4810A05417, 4810A04557, 4810A04555, 4810A04556, 4810A04504, 4810A04505, 4810A04506, 4810A04507, 4810A04508, 4810A04509, 4810A04510, 4810A04511, 4825A06062, 4825A06065, 4825A06063, 4825A06064, 4810A09047, 4810A09048, 4810A09049, 4810A09050, 4810A09051, 4810A09052, 4810A09053, 4810A09054, 4810A09055, 4810A09056, 4810A09084, 4810A09085, 4810A09086, 4810A09087, 4810A09302, 4815A05570, 4815A05571, 4815A05574, 4815A05573, 4810A05247, 4810A09756, 4810A11893, 4810A11894, 4810A10015, 4810A10016, 4810A10018, 4810A10019, 4810A10020, 4810A10021, 4810A02915, 4810A02874, 4825A06101, 4825A06102, 4825A06116, 4825A06117, 4810A09436, 4810A10078, 4810A10079, 4810A10083, 4810A09634, 4810A09635, 4810A09654, 4810A09655, 4810A09656, 4810A09657, 4810A09640, 4810A09645, 4810A09658, 4810A09641, 4810A09642, 4810A09659, 4810A09660, 4810A09661, 4810A09662, 4810A09463, 4810A09425, 4810A09462, 4810A09464, 4810A09892, 4810A09894, 4810A09876, 4810A09877, 4810A09878, 4810A09879, 4810A09880, 4810A09881, 4810A09895, 4810A09893, 4810A09882, 4810A09883, 4810A09884, 4810A05147, 4810A04228, 4810A04292, 4810A04293, 4810A04294, 4815A05914, 4815A05915, 4815A05882, 4815A05883, 4815A05884, 4815A05901, 4815A05902, 4815A05903, 4815A05904, 4815A05905, 4815A05906, 4810A02786, 4810A02787, 4810A02788, 4825A06053, 4825A06049, 4825A06050, 4825A06051, 4825A06052, 4825A06044, 4825A06045, 4825A06046, 4825A06047, 4825A06048, 4825A06092, 4825A06038, 4825A06039, 4825A06040, 4825A06041, 4825A06042, 4825A06043, 4825A06056, 4810A04970, 4810A04971, 4810A04974, 4810A04975, 4810A04976, 4810A04977, 4810A04978, 4810A04979, 4810A05030, 4810A05031, 4810A03323, 4810A03324, 4810A03325, 4810A09359, 4810A09360, 4810A05083, 4810A04544, 4810A04545, 4810A04546, 4810A04547, 4810A04548, 4810A04550, 4810A04551, 4810A04552, 4810A04553, 4810A09215, 4810A09199, 4810A09200, 4810A09201, 4810A09202, 4810A09203, 4810A09212, 4810A04558, 4810A04559, 4810A04560, 4810A04561, 4810A04562, 4810A04563, 4810A04564, 4810A04048, 4810A04049, 4810A04050, 4810A04051, 4810A11857, 4810A10087, 4810A10088, 4810A10089, 4810A10090, 4810A10091, 4810A10092, 4810A10093, 4810A10094, 4815A05948, 4815A05949, 4815A05950, 4815A05951, 4815A05895, 4815A05896, 4815A05897, 4815A05898, 4810A04812, 4810A04813, 4810A03652, 4810A03653, 4810A03839, 4810A11896, 4810A11897, 4810A03575, 4810A03576, 4810A03577, 4810A03578, 4810A03581, 4810A03582, 4810A03583, 4810A03584, 4810A05406, 4810A05407, 4810A09574, 4810A09575, 4810A09576, 4810A09577, 4810A09578, 4810A09579, 4810A04662, 4810A04673, 4810A04674, 4810A03206, 4810A04303, 4810A04304, 4810A04305, 4810A04306, 4810A04386, 4810A05459, 4810A05460, 4810A05461, 4810A05504, 4815A05813, 4815A05814, 4815A05818, 4810A04124, 4810A04125, 4810A04126, 4810A04127, 4810A04128, 4810A04129, 4810A04352, 4810A04353, 4810A04354, 4810A04355, 4815A05604, 4815A05617, 4815A05618, 4815A05619, 4815A05634, 4810A04980, 4810A04998, 4810A04999, 4810A05000, 4810A05001, 4810A05002, 4810A03229, 4810A03205, 4810A03249, 4810A03204, 4810A03230, 4810A03250, 4810A05024, 4810A04981, 4810A04982, 4810A04983, 4810A04984, 4810A05025, 4810A05026, 4810A05027, 4810A05028, 4810A05009, and 4810A05012.

510(k) numbers

["K023698"]

PMA numbers

not on file

Product code

DSI

Firm FEI

1000524572

Firm city

Bothell

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

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