Recall Z-2284-2023— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-2284-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2023-06-12. It names one FDA 510(k) clearance: K200917. Product: Azurion 7 M20. X-ray Image guided Therapy System.. Reason: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-12
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01

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

Azurion 7 M20. X-ray Image guided Therapy System.

Reason for recall

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

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