FDA Device recall Z-2383-2015
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use…
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use… by Philips Electronics North America, 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 due….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2383-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
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
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.
Identifiers
| code_info | DigitalDiagnost |
|---|
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-2383-2015%22
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