PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 28, 2024 Initiated: August 8, 2024 #Z-2716-2024

Product Description

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

Reason for Recall

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

Details

Units Affected
6 units
Distribution
Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Location
Best

Frequently Asked Questions

What product was recalled?
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 6 units.
Why was this product recalled?
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2716-2024.