Agency classClass IIOur severity:High FDA (Devices)·Z-0861-2024·Announced 2024-02-07

Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement

Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall addresses a functional defect in clinical imaging equipment where loss of connectivity disables critical movement functions. No hospitalizations or injuries have been reported, which aligns with the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Azurion 7 M20 FlexArm system with Maquet Magnus Table is being recalled by Philips Medical Systems due to a software defect. The issue involves date/time format handling that causes loss of connectivity between the FlexArm and the Table, resulting in loss of movement capability for both components.

The recall affects 108 systems distributed worldwide: 14 in the United States (across Colorado, Florida, Illinois, Mississippi, Nevada, and Texas), 1 in Canada, and 93 in other countries. Two system types are affected (System Codes 722079 and 722224) with specific serial numbers tracked by the manufacturer.

This is classified as an FDA Class II recall. The connectivity loss prevents the imaging arm and table from moving during clinical procedures, potentially affecting interventional imaging operations.

The recalled product

Product: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Interventional imaging system
Hazard: software-defect
connectivity-loss
loss-of-function

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

(1) System Code: 722079
(1) UDI/DI: 00884838085268
(1) Serial Number: 1005
866
1361
952
1241
1169
756
703351
1135
1122
824
748
630
638
703385
812
703346
1303

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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