Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
This recall is currently active, issued August 22, 2024. It was issued by Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best Netherlands.
- Recall Initiated
- August 8, 2024
- Posted
- August 22, 2024
- Recall Number
- Z-2716-2024
- Quantity
- 6 units
- Official Source
- View on FDA website ↗
Reason for Recall
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Distribution
Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Lot / Code Info
Serial Numbers: 111 138 467 817 2928 269
Root Cause
Under Investigation by firm
Action Taken
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).