Philips Healthcare DuraDiagnost X- Ray recall
Philips Healthcare DuraDiagnost X- Ray
Why was Philips Healthcare DuraDiagnost X- Ray recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
DuraDiagnost Stationary X-ray System.
- Product
- Philips Healthcare DuraDiagnost X- Ray
- Recalling firm
- Philips Medical Systems, Inc.
- Quantity
- 3 DuraDiagnost
- 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.
- Recall date
- May 27, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)