X-ray therapy system carriage bolts may loosen and suspension rail crack
Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.
What this means for you
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: FDA Class II medical device recall involving structural defects (loose or broken carriage bolts, cracked suspension rail) in critical equipment components. No injuries or illnesses have been reported, limiting the score to High per the rubric.
Plain-English summary
This recall affects the Azurion 7 M20 X-ray Image guided Therapy System, made by Philips Medical Systems Nederland B.V. The FlexMove Carriage component has supporting bolts that may become loose and/or break, and its suspension rail may develop cracks.
The recall affects 648 units worldwide, including throughout the United States and in approximately 50 other countries.
Healthcare facilities with potentially affected equipment should contact Philips Medical Systems to verify their device models (722079 or 722224) and to obtain instructions for inspection, repair, or replacement.
The recalled product
- Product
- Azurion 7 M20. X-ray Image guided Therapy System.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Imaging / X-ray
- Hazard
- loose-bolts
- broken-bolts
- cracked-rail
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)
- Model No.: 722079
- 722224
- UDI-DI: (01)00884838085268(21)
- (01)00884838099258(21)
- System Equipment Number: 69991047
- 69991048
- 71927518
- 71929379
- 71929381
- 71929386
- 71934809
- 71935340
- 71937626
- 71939045
- 71957323
- 72045694
- 72150041
- 72173543
- 72273457
- 72312081
Distribution
Distributed nationwide across the United States.
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