Device product
Philips Healthcare DuraDiagnost X- Ray
Z-1555-2015
Product summary
- Event
- Event 70916
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 DuraDiagnost
- Official record key
device-enforcement:Z-1555-2015
Official wording
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).
Code information: DuraDiagnost Stationary X-ray System.
Distribution pattern: Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.
Derived failure modes
-
Unknown
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).