Philips DigitalDiagnost 3 — Class II medical device recall Z-2154-2017
Terminated recall by Philips Electronics North America Corporation, reported 2017-06-21, distributed nationwide. During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may
| Recall number | Z-2154-2017 |
|---|---|
| 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 | 2017-05-11 |
| Classified | 2017-06-09 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 132 |
Product
Philips DigitalDiagnost 3.1.x X-Ray System
Reason for recall
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
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-2154-2017. 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.