Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

FDA device recall Z-1177-2024 · posted 2024-02-22 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.

Action taken

Philips notified U.S customers by Urgent Medical Device Correction letter on 06-Feb-2024 via certified mailing via United States Postal Service. " Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk, and action to take: Circulate this Letter to all clinical staff and any service personnel that may service the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction Letter with the documentation of the system until Philips implements the correction in your system. " If the Certeray generator fails, please stop using the system and contact the Customer Care Solutions Center. " Place a copy of this Letter in a visible place in the Control and Technical rooms (e.g., posted on the door). " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGTS to correct the problem As a remedy, Philips will replace the Power Inverter in the Azurion generator cabinet in all affected Azurion systems through the implementation of Field Change Order (FCO72200544). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWB

Quantity affected

27 units

Distribution

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuado

Date initiated

2024-02-06

Date posted

2024-02-22

Location

Best, Netherlands

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