Recalls / —

—#48181

Product

Allura Xper FD 10/10 x-ray, angiographic system

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K041949

Affected lot / code info

Site numbers for both FD 10/10 and FD 10:  532800, 544506, 543702, 543289, 543209, 543200, 543194, 542714, 542557, 542413, 542117, 542113, 541822, 541592, 541577, 541409, 541029, 541026, 540841, 540488, 540386, 540311, 540301, 540269, 540237, 540235, 540234, 540184, 540070, 540016, 539641, 539628, 539595, 539480, 539455, 539326, 539107, 538903, 538744, 538516, 538514, 538486, 538485, 538476, 538409, 538368, 538157, 538084, 538028, 537855, 537804, 537745, 537698, 537631, 537630, 536966, 536721, 536379, 536138, 536042, 536037, 536035, 536034, 536031, 536028, 535769, 535667, 535416, 535415, 534941, 534731, 534678, 534638, 534634, 533762, 533397, 533289, 533283, 533282, 533278, 532799, 532611, 531942, 530667, 530666, 104497, 103283

Why it was recalled

Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.

Root cause (FDA determination)

Other

Action the firm took

A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-08-24

Posted by FDA

2006-11-08

Terminated

2008-05-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.