Reported Aug 9, 2023 · Ongoing
Allura Xper FD10 and FD20. X-ray Imaging 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?
- Allura Xper FD10 and FD20. X-ray Imaging System.
- Lot codes and dates
Model No.: 722010722012722022722023722026722028722033722035
- UDI-DI
(01)00884838054189(21)(01)00884838054202(21)(01)00884838054240(21)(01)00884838059054(21)(01)00884838059085(21)(01)00884838059191(10)(01)00884838059283(10)
- System Equipment Number
457 of 457 codes
527564505315228053339159533411095336264953367108534174345349974553532256535447355356403853758475537609035386195553882172539251335395385753954111539778855422878654367887544398625443991354635472546501735465017654803862548122175485320354861346548779255497230655063750551028095510341855126283551377225513933755236546552709075528932555310609553668025537803855379838554166345542393455424653554316325543212055624201556515625583502256012278560347325607769456131358562826145631002256552489
- 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.
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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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