FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: ALLURA XPER FD20/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
- Recall number
- Z-0549-2011
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- ALLURA XPER FD20/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
- Status
- Terminated
- Initiated
- 2009-05-26
- Posted
- 2010-12-07
- Terminated
- 2010-12-09
- Reason
- The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start.
- Root cause
- Other
- Action
- Philips began mailing out an URGENT-Device Correction letter on May 26, 2009. Philips sent out a second URGENT-Device Correction letter dated June 4, 2009, to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to contact their local Philips representative immediately if their system completely shut down and would not restart. A mandatory Field Change Order 72200144 was issued for replacement of the Printed Circuit Board (PCB) in the Allura XPER FD system. A mandatory Field Change Order FCO 70800091 was issued for replacement of the Printed Circuit Board (PCB) in the MultiDiagnost Eleva with FD system. The consignees were to be contacted by their Philips Representative for implementation of the corrective action. The firm's Field Engineer would replace the power tray of the systems. If the consignees needed any further information or support concerning this issue, they were to contact the call Center at 800-722-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.
- Quantity
- 8 units
- Distribution
- Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.
- Lot, serial or model codes
- Site numbers: 41445615, 41445628, 42479274, 42508759, 43315510, 43436747, 43443622, and 43635004.
- 510(k) numbers
- not on file
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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