Z-1555-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2015
- Initiation Date
- February 9, 2015
- Termination Date
- June 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 DuraDiagnost
Product Description
Philips Healthcare DuraDiagnost 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).
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.
Code Information
DuraDiagnost Stationary X-ray System.