Reported Mar 7, 2018 · Terminated
digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic…
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations, including specialist area like intensive care, trauma, or pediatric work, excluding mammography
- United States onlyThe Eleva Workspot is not intended for fluoroscopy and angiography
- Lot codes and dates
- ProGrade R1, solid state X ray imager, 712090 Serial #s:
157 of 157 codes
SN17000011SN15000026SN17000022SN15000038SN16000001SN14000035SN17000020SN17000003SN17000008SN17000013SN14000024SN14000034SN15000012SN15000024SN15000022SN16000035SN17000018SN17000024SN15000049SN16000006SN16000010SN17000001SN17000023SN15000042SN16000011SN16000020SN14000007SN17000025SN15000051SN15000028SN17000014SN15000016SN15000035SN17000015SN16000041SN16000022SN16000007SN15000005SN16000009SN16000040SN15000046SN16000016SN16000015SN14000013SN15000006SN17000030SN16000012SN16000014SN15000039SN16000039SN14000028SN15000032SN16000042SN17000021SN15000013SN17000007SN15000047SN16000024SN17000002SN17000005
- ProGrade R1, solid state X ray imager, 712090 Serial #s:
- Amount recalled
- 157
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. The image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. To continue, the operator can reset the SkyPlate detector by removing its batteries, but the acquired image is lost and a re-take is necessary.
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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