Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 0...
FDA Recall #Z-0860-2024 — Class II — December 8, 2023
Product Description
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Reason for Recall
Loss of connectivity between the FlexArm and the Table due to a software issue.
Recalling Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
28 systems (9 US, 1 Canada, 18 ROW)
Distribution
Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Code Information
(1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1086, 1392, 703615, 1079, 743, 703456, 1248; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.