Philips Medical Systems North America Co. Phillips: Philips Easy Diagnost X-Ray System

Recall number

Z-0909-2007

Recalling firm

Philips Medical Systems North America Co. Phillips

Product

Philips Easy Diagnost X-Ray System

Status

Terminated

Initiated

2007-07-23

Posted

2007-09-25

Terminated

2012-09-17

Reason

Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.

Root cause

Other

Action

On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.

Quantity

709 units + 31 units added = 740

Distribution

Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.

Lot, serial or model codes

Site numbers   6961, 6962, 6963, 6964, 6965, 6966, 6967, 6968, 6969, 6970, 6971, 6972, 6973, 6974, 6975, 86401, 100727, 102386, 102553, 250068, 250410, 250828, 505640, X1072, X1075, X1135, X1218, X1297, X1302, X1401, X1708, X1750, X1770, X1771, 250302   6901, 6961, 6983, 6987, 10000, 10002, 10006, 10178, 10392, 10393, 10406, 10410, 10418, 10435, 10493, 13173, 13178, 13195, 13215, 13245, 13257, 13283, 13284, 13293, 13877, 13880, 13895, 13908, 13956, 13968, 13969, 13970, 13972, 13984, 13999, 14070, 14169, 14177, 26140, 26154, 26157, 26211, 26212, 26213, 26275, 38086, 38091, 38106, 38120, 38141, 38142, 38149, 38195, 38196, 38207, 38268, 38279, 38314, 38318, 38361, 38417, 38423, 38424, 38434, 38505, 38528, 38529, 38539, 38541, 38555, 38559, 38584, 38591, 38607, 38608, 38625, 38626, 38634, 38656, 38679, 38689, 38692, 38693, 38695, 38712, 38743, 38745, 38914, 38940, 38958, 38972, 38977, 38978, 38988, 40930, 40936, 40937, 40973, 41035, 41040, 41063, 41096, 41098, 41099, 41105, 41107, 41120, 41121, 41131, 41135, 41235, 41236, 41237, 41238, 41284, 41286, 41352, 41420, 41435, 41463, 41465, 41466, 41468, 44804, 44805, 44806, 44983, 45029, 45070, 45091, 45092, 50220, 50221, 50230, 50322, 50323, 50427, 50446, 50447, 52450, 52456, 52491, 59569, 59634, 59652, 59661, 59666, 62663, 62664, 62797, 62802, 62838, 62868, 62888, 62889, 62934, 62973, 62987, 62994, 62996, 62997, 73858, 76192, 76216, 76355, 76356, 76357, 76371, 76372, 76379, 76381, 76382, 76391, 76403, 76439, 76456, 76495, 76578, 76763, 76805, 76827, 76829, 76837, 76838, 76843, 76844, 76874, 76925, 76940, 76957, 76958, 76959, 76960, 76965, 76967, 76973, 76982, 80318, 80319, 80339, 82503, 82515, 82516, 82561, 82570, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82918, 82920, 82942, 82943, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83646, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84459, 84460, 84461, 84703, 84704, 84851, 84857, 84858, 84889, 84893, 84895, 84928, 84931, 84936, 84938, 84939, 84949, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85161, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85464, 85465, 85467, 85484, 85486, 85487, 85492, 85493, 85494, 85683, 86015, 86059, 86060, 86070, 86071, 86078, 86140, 86213, 86215, 86216, 86221, 86226, 86228, 86229, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86387, 86389, 86391, 86394, 86395, 86397, 86400, 86403, 86543, 86547, 86579, 86600, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86624, 86901, 86903, 86938, 86939, 86942, 86964, 86966, 86970, 86976, 86979, 86980, 87005, 87016, 87017, 87031, 87045, 87046, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87177, 87178, 87196, 87313, 87320, 87333, 87363, 87510, 87520, 87601, 87609, 87610, 100428, 100438, 100443, 100457, 100481, 100489, 100495, 100518, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100676, 100677, 100698, 100727, 100770, 100818, 100834, 100835, 100838, 100848, 100855, 100867, 100876, 100882, 100883, 100947, 100957, 101039, 101041, 101054, 101076, 101079, 101080, 101132, 101133, 101134, 101141, 101142, 101143, 101144, 101145, 101147, 101148, 101149, 101161, 101191, 101204, 101212, 101240, 101555, 101558, 101563, 101569, 101586, 101643, 101837, 101871, 101872, 101935, 101936, 101937, 101955, 101958, 101959, 101960, 102099, 102107, 102132, 102163, 102168, 102169, 102170, 102174, 102245, 102337, 102338, 102339, 102341, 102342, 102372, 102376, 102384, 102385, 102387, 102388, 102445, 102462, 102466, 102491, 102541, 102552, 102559, 102567, 102585, 102586, 102587, 102590, 102591, 102606, 102608, 102609, 102622, 102630, 102634, 102647, 102700, 102701, 102794, 102839, 102876, 102893, 102903, 102917, 102918, 102921, 102922, 102925, 103007, 103008, 103037, 103057, 103115, 103120, 103121, 103146, 103163, 103180, 103184, 103185, 103200, 103204, 103252, 103260, 103276, 103279, 103284, 103310, 103337, 103387, 103421, 103422, 103424, 103427, 103496, 103497, 103504, 103517, 103595, 103597, 103606, 103653, 103724, 103730, 103785, 103786, 103876, 103883, 103895, 103917, 103943, 103948, 103963, 103977, 104010, 104013, 104051, 104059, 104071, 104113, 104135, 104153, 104162, 104164, 104165, 104181, 104182, 104204, 104205, 104268, 104283, 104339, 104404, 104471, 104508, 104629, 104794, 104801, 104842, 104854, 104855, 104881, 104893, 104931, 105109, 105155, 105202, 105238, 105242, 105295, 105337, 105414, 105649, 105696, 105769, 250043, 250069, 250092, 250139, 250313, 250679, 500012, 504137, 504329, 504882, 505056, 505640, 506168, 506171, 519562, 519766, 519776, 519826, 520262, 520279, 520280, 521003, 530692, 532044, 534057, 534433, 534873, 535262, X1027, X1041, X1055, X1056, X1089, X1136, X1140, X1141, X1142, X1153, X1165, X1166, X1180, X1181, X1194, X1201, X1229, X1230, X1234, X1264, X1266, X1290, X1295, X1299, X1304, X1320, X1338, X1362, X1363, X1399, X1405, X1417, X1446, X1449, X1467, X1469, X1501, X1502, X1504, X1507, X1510, X1515, X1521, X1543, X1561, X1565, X1568, X1569, X1572, X1573, X1632, X1640, X1644, X1653, X1671, X1681, X1705, X1706, X1713, X1749, X1752, X1764, X1769  sites added - 6664, 38342, 76502, 103539, 103953, 103980, 105337, 105640, 250068, 250410, 504541, 504743, 505057, 506076, 506207, 506273, 520527, 521825, 530806, 543660, 543754, 545391, 546155, 546202, 546578, 547017, 547142, 553287, 557983, 557996, and 49794697.

510(k) numbers

["K970640"]

PMA numbers

not on file

Product code

IXR

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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