FDA Device recall Z-1555-2015
Philips Healthcare DuraDiagnost X- Ray
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of Philips Healthcare DuraDiagnost X- Ray by Philips Medical Systems, citing 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. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1555-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-09 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips Healthcare DuraDiagnost X- Ray
Reason
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).
Identifiers
| code_info | DuraDiagnost Stationary X-ray System. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1555-2015%22
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