Philips DuraDiagnost stationary X-ray system — Class II medical device recall Z-2682-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-09-07, distributed in CA, ME, NC, NE, OH, OR, TX, WA. Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep w
| Recall number | Z-2682-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2015-09-17 |
| Classified | 2016-09-01 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-08-31 |
| Distributed | CA, ME, NC, NE, OH, OR, TX, WA |
| Quantity | 15 |
| Reason classes | labeling |
Product
Philips DuraDiagnost stationary X-ray system
Reason for recall
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
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-2682-2016. 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.