FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
- Recall number
- Z-2716-2024
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
- Status
- Open, Classified
- Initiated
- 2024-08-08
- Posted
- 2024-08-22
- Terminated
- not on file
- Reason
- A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
- Root cause
- Under Investigation by firm
- Action
- An URGENT Medical Device Correction notification letter dated 7/31/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients. a. Affected systems may continue to be used in accordance with the Instructions for Use (IFU). b. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. c. Circulate this notice to all users of the system so that they are aware of the issue. d. Should you experience uncontrolled C-arm movement, call your local Philips representative to report the event. e. Return the attached response form to Philips promptly and no later than 30 days from receipt to confirm that the users of the system have reviewed and understood this Medical Device Correction and required actions to be taken. Actions planned by Philips IGT-S to correct the problem Philips will contact all affected customers to arrange for a Field Service Engineer visit to install an updated Lifetime Extension Kit with the correct full-threaded bolt (reference FCO72200590). If you need any further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
- Quantity
- 6 units
- Distribution
- Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
- Lot, serial or model codes
- Serial Numbers: 111 138 467 817 2928 269
- 510(k) numbers
- ["K161563"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
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