|
Medical Device Recalls
Class 2 Recall
Integris Allura
|
|
Date Recall Initiated |
December 14, 2006
|
Date Posted |
January 25, 2007
|
Recall Number |
Z-0366-2007
|
Product |
Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mono-plane analog Allura with a 9' Image Intensifier
|
Code Information |
site numbers 534928, 545964, 532207, 545365, 538387, 543397, 543398, 543399, 546572, 544581, 544728, 548147, 547005, 539456, 543953, 547234, 547364, 545838, 545839, 545840, 544395, 547952, 530393, 545799, 540790, 547431, 544122, 541659, 546060, 543433, 545604, 543198, 545921, 545640, 545966, 541590, 540456, 546201, 541572, 544130, 544635, 534665, 542963, 535303, 541783, 544631, 540930, 544610, 544506, 546456, 544989, 544990, 544992, 543984, 543759, 546906, 543873, 543087, 543108, 547279, 546908, 544750, 545518, 545052, 545539, 543799, 543411, 547660, 543229, 544371, 548288, 546668, 545714, 537604, 541046, 544513, 545583, 540808, 545280, 548039, 544489, 544120, 540275, 540284, 540952, 544637, 547855, 545941, 545753, 541597, 545025, 536030, 544543, 546693, 548140, 546025, 545752, 547976, 543971, 543972, 539634, 545749, 546119, 545750, 547642, 544433, 545069, 545073, 547777, 547321, 547628, 545733, 547392, 545293, 545296, 547908, 541880, 543386, 546013, 548061, 545282, 533398, 541588, 541589, 540374, 545357, 542486, 545443, 546012, 545090, 545037, 538432, 532226, 540407, 103281, 104950, 531926, 104953, 530653, 520630
|
Recalling Firm/ Manufacturer |
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell
, Washington
98021-8431
|
For Addition Information Contact |
Sarah Baxter
425-487-7665
|
Reason For Recall |
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
|
Action |
On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.
|
Quantity in Commerce |
140 devices total
|
Distribution |
Units were distributed to hospitals and medical centers nationwide.
|
|
|
|
|
|