digital x-ray detector ProGrade R1 — Class II medical device recall Z-0704-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-03-07, distributed nationwide. It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to trans
| Recall number | Z-0704-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2017-12-11 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 157 |
| Reason classes | device malfunction |
| Serial numbers | SN14000001, SN14000003, SN14000004, SN14000005, SN14000006, SN14000007, SN14000008, SN14000009, SN14000010, SN14000011, SN14000012, SN14000013, SN14000014, SN14000015, SN14000016, SN14000017, SN14000018, SN14000019, SN14000020, SN14000021, SN14000022, SN14000023, SN14000024, SN14000025, SN14000026 and 132 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0704-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.