Recall Z-2716-2024— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-2716-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2024-08-08. It names one FDA 510(k) clearance: K161563. Product: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013. Reason: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-08
Firm location: Best, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K161563 — Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.·cleared 2016-07-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.