—#73599

Product

Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041949
Affected lot / code info: Devices are identified with Site Numbers: 14147, 38377, 505254, 544048, 544051, 548067, 549738, 550172, 552470, 552585, 552586, 553234, 553351, 553352, 553925, 554019, 554427, 554431, 554442, 554444, 554550, 554556, 554631, 554745, 554768, 554791, 555206, 556311, 556708, 556783, 557512, 41416358, 41443581, 41443882, 41444662, 41445645, 41446080, 41446144, 41446290, 41446807, 41455906, 41903960, 42393465, 43067304, 43719245, 44048177, and 44604746.

Why it was recalled

Due to a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software. For question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Devices were distributed to hospitals and medical facilities through out the U.S.

Timeline

Recall initiated: 2008-08-21
Posted by FDA: 2010-10-22
Terminated: 2010-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.