Recall Z-1177-2024— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1177-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-06

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2024-02-06. It names one FDA 510(k) clearance: K200917. Product: Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228. Reason: Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-06
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 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

Reason for recall

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

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