510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0908-2007

Philips Digital Diagnost X-Ray system

Philips North America LLC / initiated 2007-07-23 / Terminated
FDA source (opens on fda.gov)

Philips Medical Systems North America Co. Phillips began a recall of Philips Digital Diagnost X-Ray system on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0908-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Philips Digital Diagnost X-Ray system
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall
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.
FDA 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 in commerce
6 units + 227 units added = 233
Distribution
Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
Product codes and lots
Site numbers 103982, 104073, 105158, 105629, 504343, 505773.  Added sites: 104303, 38280, 44807, 59667, 76907, 76909, 76974, 82641, 82652, 82657, 82724, 83072, 83073, 84712, 84862, 84863, 86072, 86987, 86988, 102030, 102100, 102489, 102713, 102717, 102719, 102787, 102905, 102911, 103109, 103165, 103274, 103437, 103438, 103439, 103453, 103893, 103894, 103941, 104465, 104902, 104903, 104904, 104937, 104938, 105415, 105621, 105623, 105625, 105668, 250094, 250470, 250471, 250875, 500002, 504546, 504989, 505038, 505347, 505350, 505351, 505352, 505605, 505684, 505944, 506184, 506343, 506643, 506645, 506826, 506839, 506848, 519148, 519149, 519150, 519568, 519739, 519904, 520297, 520298, 520299, 520385, 520687, 520698, 520766, 520808, 520811, 520828, 520836, 520978, 520984, 520986, 521004, 521089, 521110, 521412, 521539, 521660, 521668, 521893, 521894, 521995, 521997, 522213, 522215, 522244, 522281, 522360, 522361, 522362, 522364, 522367, 522398, 522475, 530411, 530412, 530415, 530455, 530516, 530611, 530696, 530716, 530779, 530787, 530789, 530791, 530792, 530796, 530800, 530806, 531773, 531825, 531833, 531858, 531975, 531994, 531995, 532138, 532141, 532167, 532168, 532169, 532171, 532206, 532211, 532278, 532364, 532421, 532422, 532815, 532816, 532817, 532818, 533244, 533317, 533319, 533338, 533426, 533468, 533534, 533571, 533769, 533915, 533916, 533920, 533949, 533950, 534082, 534279, 534435, 534539, 534570, 534622, 534718, 534800, 534801, 534836, 534866, 535146, 535334, 535381, 535383, 535549, 535626, 535773, 535774, 535786, 535933, 536002, 536039, 536043, 536062, 536064, 536128, 536129, 536441, 536448, 536614, 536913, 536939, 537163, 537184, 537455, 537753, 537755, 537762, 537840, 537918, 537948, 537950, 537974, 538139, 538154, 538166, 538304, 538437, 538478, 539680, 540173, 540199, 540474, 540477, 542194, 543376, 545097, 549011, 549725, and 557777.