Allura Xper FD10/10 Biplane 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.
This recall has been terminated (originally issued October 22, 2010).
- Recall Initiated
- August 21, 2008
- Posted
- October 22, 2010
- Terminated
- November 19, 2010
- Recall Number
- Z-0125-2011
- Quantity
- 26 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for table and stand not to move due to a software error.
Distribution
Devices were distributed to hospitals and medical facilities through out the U.S.
Lot / Code Info
Devices are identified with Site Numbers: 103281, 103283, 505903, 506119, 530653, 536715, 543411, 545396, 547823, 549368, 552969, 554802, 554970, 555293, 555299, 555834, 41443647, 41443804, 41444650, 41445448, 41445501, 41445538, 41455920, 41780160, 42057324, and 42064724.
Root Cause
Software design
Action Taken
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.