Reported Dec 15, 2021 · Ongoing
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number:…
Philips North America LLC
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 North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system
- Model Number718075
- Lot codes and dates
- Serial Number
173105530149505360465148918731633160543562204509050915092484050731253833845121
- UDI(01)00884838055490(21)173 (01)00884838055490(21)105 (01)00884838055490(21)5301 (01)00884838055490(21)4950 (01)00884838055490(21)5360 (01)00884838055490(21)4651 (01)00884838055490(21)4891 (01)00884838055490(21)873 (01)00884838055490(21)1633 (01)00884838055490(21)160 (01)00884838055490(21)543 (01)00884838055490(21)562 (01)00884838055490(21)204 (01)00884838055490(21)5090 (01)00884838055490(21)5091 (01)00884838055490(21)5092 (01)00884838055490(21)4840 (01)00884838055490(21)5073 (01)00884838055490(21)125 (01)00884838055490(21)383 (01)00884838055490(21)384 (01)00884838055490(21)5121
- Serial Number
- Amount recalled
- 22 units US
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
This product could cause temporary or reversible health problems — stop using it.
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