FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
- Recall number
- Z-2471-2010
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
- Status
- Terminated
- Initiated
- 2008-10-23
- Posted
- 2010-09-22
- Terminated
- 2011-08-10
- Reason
- A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.
- Root cause
- Other
- Action
- The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.
- Quantity
- 70 units in US
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Devices are identified as Site Numbers: 538028, 536037, 536035, 536034, 536031, 536042, 536028, 537631, 538157, 537804, 538409, 538516, 538514, 539628, 540237, 540184, 539326, 542714, 542557, 538387, 542413, 543200, 543411, 541577, 543879, 543289, 541589, 544395, 545025, 544433, 545604, 545753, 541590, 546013, 548140, 546569, 543989, 547922, 548288, 547173, 545997, 545884, 549903, 551855, 547769, 41444647, 41455885, 41455897, 545396, 554802, 549368, 555293, 547823, 555834, 555299, 41443804, 554970, 41444650, 41455920, 41445448, 41445501, 41780160, 41445538, 41443647, 42064724, 42057324, 103281, 103283, 530653, and 505903.
- 510(k) numbers
- ["K031333","K984545"]
- 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