Z-1554-2015 Class II Terminated
FDA device recall Z-1554-2015 was initiated by Philips Medical Systems, Inc. on February 9, 2015 and is designated Class II. 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 … The recall status is terminated (terminated June 14, 2016). Affected quantity: 54 DigitalDiagnost.
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
- 54 DigitalDiagnost
Product Description
Reason for Recall
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.