Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7220

FDA device recall Z-0835-2024 · posted 2024-01-26 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

Action taken

On December 12, 2023, the firm notified customers via certified mailing of URGENT Medical Device Correction letters. Customers may identify affected products by the system product name and model number, which can be found on the System Identification Label located on the system stand. The software version of the Philips Azurion system can be identified during start-up. Customers were advised to keep the number of studies in the patient database as low as possible, but at least below 500. Customers should keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system. Ensure that all users of the system are notified of the issue. Philips is working on a software release that will correct this issue. Philips representatives will contact affected customers to schedule the correction. Please contact your local Philips representative for further information or support concerning this issue.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWB

Quantity affected

1,799 US; 5,747 OUS

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2023-12-12

Date posted

2024-01-26

Location

Best, Netherlands

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