Recall Z-0353-2025— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-0353-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-07

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2024-10-07. It names one FDA 510(k) clearance: K212813. Product: Philips Zenition 70, Model Number: 718133. Reason: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2024-10-07
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K212813 — Zenition 70Philips Medical Systems Nederland B.V.·cleared 2021-10-01

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

Philips Zenition 70, Model Number: 718133

Reason for recall

Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

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