Philips Healthcare DigitalDiagnost System X-Ray — Class II medical device recall Z-1554-2015
Terminated recall by Philips Medical Systems, Inc., reported 2015-05-27, distributed nationwide. The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered
| Recall number | Z-1554-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2015-02-09 |
| Classified | 2015-05-21 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2016-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, CA, CH, CL, CN, CO, CZ, DE, EG, ES, FI, FR, GB, IE, IN, JP, MX, MY, NL, NP, NZ, PE, PL, RU, SA, SE, SG |
| Quantity | 54 digitaldiagnost |
Product
Philips Healthcare DigitalDiagnost System X-Ray
Reason for recall
The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
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-1554-2015. 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.