FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: 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.
- Recall number
- Z-0124-2011
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- 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.
- Status
- Terminated
- Initiated
- 2008-08-21
- Posted
- 2010-10-22
- Terminated
- 2010-11-19
- Reason
- 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
- Software design
- Action
- 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.
- Quantity
- 47 units
- Distribution
- Devices were distributed to hospitals and medical facilities through out the U.S.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K041949"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28