Agency classClass IIOur severity:High FDA (Devices)·Z-2134-2025·Announced 2025-07-30

Azurion 7 M20 C-arm gearbox mounting bolts may become loose

The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.

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: Risk-of-harm product: fasteners securing a moving C-arm assembly may loosen above a patient, with no injury reported in the source.

Plain-English summary

The Azurion 7 M20 fluoroscopic x-ray system, system model number 722079, UDI 00884838085268, is being recalled. The action covers 78 units, identified by the serial numbers in the recall notice.

The stated reason is the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States across California, Colorado, the District of Columbia, Delaware, Florida, Illinois and Indiana among other states. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model number, UDI and serial numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product: Azurion 7 M20. Fluoroscopic X-Ray System.
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Fluoroscopic x-ray system
Hazard: loose-bolts
c-arm
mechanical-fastener
class-ii
Affected units: 78

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)

System Model No. 722079
UDI: 00884838085268
Serial No. 525
584
587
613
631
658
708
774
777
793
800
801
838
842
843
862
865
866

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · loose bolts