Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to A half-threaded bolt was included in the LTE...

Date: August 8, 2024
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly.

Affected Products

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

Quantity: 6 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report