FDA recall Z-2716-2024

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-08-08
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2716-2024