Philips Healthcare DigitalDiagnost stationary X-ray system — Class II medical device recall Z-1695-2016
Terminated recall by Philips Healthcare, reported 2016-06-15, distributed nationwide. The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to prop
| Recall number | Z-1695-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2015-11-10 |
| Classified | 2016-06-03 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 160 |
Product
Philips Healthcare DigitalDiagnost stationary X-ray system
Reason for recall
The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
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-1695-2016. 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.