—#209596

Product

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K161563
Affected lot / code info: Serial Numbers: 111 138 467 817 2928 269

Why it was recalled

A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.

Timeline

Recall initiated: 2024-08-08
Posted by FDA: 2024-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.