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.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Medical Device Recall: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013 | SafeCheck