Reported Aug 9, 2023 · Ongoing
Azurion 7 M20. X-ray Image guided Therapy System.
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Azurion 7 M20. X-ray Image guided Therapy System.
- Lot codes and dates
Model No.: 722079722224
- UDI-DI
(01)00884838085268(21)(01)00884838099258(21)
- System Equipment Number
191 of 191 codes
699910476999104871927518719293797192938171929386719348097193534071937626719390457195732372045694721500417217354372273457723120817232135672327897724007077241498972419144724264027264885772719305727198207272195972748229727712847280553072933546730008627300343773011242730518577333731073337321733394547334055473407813734614477351669673581917735819687361673273625357736331047371729173861967740175567402068274095702741546907415469174155276741690497422723074227231742380847425040474288937
- Amount recalled
- 648 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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