Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected

FDA device recall Z-1145-2024 · posted 2024-02-16 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

Action taken

On January 2, 2024, the firm notified affected consignees via URGENT Medical Device Correction letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card. This recall record is for the Framegrabber Card issue. Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be corrected. Philips will be replacing the three components in all affected systems. Philips will contact customers to schedule a visit to replace the affected components. If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).

Root cause

Process design

Status

Open, Classified

Product code

OWB

Quantity affected

1,993 US; 2,662 ROW

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2024-01-02

Date posted

2024-02-16

Location

Best, Netherlands

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