Philips Healthcare DuraDiagnost X- Ray
This recall has been terminated (originally issued May 19, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- February 9, 2015
- Posted
- May 19, 2015
- Terminated
- June 14, 2016
- Recall Number
- Z-1555-2015
- Quantity
- 3 DuraDiagnost
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
DuraDiagnost Stationary X-ray System.
Root Cause
Software design (manufacturing process)
Action Taken
Philips Healthcare Planned action: 1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem. 2. Philips engineers will install the software. 3. Philips engineers will perform testing to ensure the software update was effective. 4. Corrections are to be made free of charge 5. Corrective actions should be completed by August 15, 2015 For further questions call (978) 659-7892