Recall Z-1555-2015 ยท KPR System, X-Ray, Stationary
Philips Medical Systems, Inc.
Philips Healthcare DuraDiagnost X- Ray
| Date | May 19, 2015 (initiated Feb 9, 2015) |
| Status | Terminated |
| 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). |
| Root cause | Software design (manufacturing process) |
| Action | 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 |
| 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, Russi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141381 | DURADIAGNOST Philips Healthcare (Suzhou) Co., Ltd., Jun 12, 2014 |