Philips Azurion 7 M20 X-Ray System C-Arm Gearbox Bolts May Loosen
Philips is recalling Azurion 7 M20 fluoroscopic X-ray systems due to potential loosening of bolts connecting the gearbox to the C-arm mounting flange. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for medical imaging equipment due to a potential mechanical issue. No incidents, injuries, or equipment failures have been reported. The recall is a precautionary measure to prevent future problems from a theoretical hazard.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Azurion 7 M20 fluoroscopic X-ray system. Approximately 78 units were distributed worldwide, including to multiple US states (California, Colorado, Delaware, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, Washington, Washington DC) and internationally to Argentina, Australia, Canada, Chile, Dominican Republic, Egypt, France, Germany, Italy, Japan, Mexico, Netherlands, New Zealand, Oman, Saudi Arabia, South Korea, Spain, Thailand, United Kingdom, and Vietnam.
The recall was initiated due to the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. This mechanical issue could compromise the stability and safe operation of the fluoroscopic imaging system.
Facilities operating Azurion 7 M20 systems (Model No. 722079, UDI 00884838085268) should verify whether their equipment is among the affected units using the serial numbers provided in the recall and contact Philips Medical Systems Nederland B.V. for guidance on corrective action.
The recalled product
- Product
- Azurion 7 M20. Fluoroscopic X-Ray System.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- mechanical-defect
- equipment-failure
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.
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