FDA Device recall Z-0704-2018
digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips P…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips P… by Philips Electronics North America, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0704-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-11 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
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 only: The Eleva Workspot is not intended for fluoroscopy and angiography.
Reason
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.
Identifiers
| code_info | ProGrade R1, solid state X ray imager, 712090 Serial #s: SN17000011 SN15000026 SN17000022 SN15000038 SN16000001…ProGrade R1, solid state X ray imager, 712090 Serial #s: SN17000011 SN15000026 SN17000022 SN15000038 SN16000001 SN14000035 SN17000020 SN17000003 SN17000008 SN17000013 SN14000024 SN14000034 SN15000012 SN15000024 SN15000022 SN16000035 SN17000018 SN17000024 SN15000049 SN16000006 SN16000010 SN17000001 SN17000023 SN15000042 SN16000011 SN16000020 SN14000007 SN17000025 SN15000051 SN15000028 SN17000014 SN15000016 SN15000035 SN17000015 SN16000041 SN16000022 SN16000007 SN15000005 SN16000009 SN16000040 SN15000046 SN16000016 SN16000015 SN14000013 SN15000006 SN17000030 SN16000012 SN16000014 SN15000039 SN16000039 SN14000028 SN15000032 SN16000042 SN17000021 SN15000013 SN17000007 SN15000047 SN16000024 SN17000002 SN17000005 SN14000022 SN17000004 SN16000030 SN16000031 SN16000032 SN14000006 SN15000033 SN16000021 SN16000029 SN14000016 SN15000031 SN14000003 SN14000014 SN15000019 SN14000023 SN16000019 SN16000038 SN16000017 SN16 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0704-2018%22
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