Health product recall

Azurion 7 M20

Last updated

Summary

Product
Azurion 7 M20
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Azurion 7 M20

All lots.

722 224

Issue

Philips has become aware of two potential safety issues with the Azurion 7 M20 Flexarm System ("flexarm") with a Maquet Magnus Table with software version 05.02.12 ("table"). Due to communication issues between the flexarm and the table, motorized movements of the table and/or the flexarm may be lost. There can be a connection issue (software issue with table to be corrected in field action FCO72200557). There is also a date and time issue where when the flexarm system is (re)started, the flexarm and table may not connect due to a software issue. This occurs when the date/time format includes more than three (3) leading zeros (to be corrected  in field action FCO72200528).

Recall start date: December 13, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74842

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