Class II

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

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · August 8, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

6 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2716-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.