Philips DigitalDiagnost Release 4 — Class II medical device recall Z-2383-2015
Terminated recall by Philips Electronics North America Corporation, reported 2015-09-02, 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-2383-2015 |
|---|---|
| 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 | 2015-03-23 |
| Classified | 2015-08-22 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 62 |
Product
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
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 due to a defect in the Microsoft Windows 7 operating system.
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-2383-2015. 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.