Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA Recall Z-0860-2024 · Posted 2024-01-30
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Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-12-08
Product Quantity28 systems (9 US, 1 Canada, 18 ROW)
Reason for Recall
Loss of connectivity between the FlexArm and the Table due to a software issue.
Firm Action
The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 12/08/2023 by certified mail to consignees. Consignees with affected devices are asked to utilize the provided workaround instructions. Additionally, consignees are asked to make all users aware of this recall notification and keep a copy of this notification with system documentation. Getinge Field Service Engineers will be dispatched to the field to install software updates to affected devices. Consignees with any questions can contact the recalling firm by phone at 1-800-722-9377. Consignees are asked to return the provided response form to the recalling firm at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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