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.
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: 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
- Affected units
- 648
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.
Part of a larger recall action
This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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