Recall Z-1178-2012 ยท KPR System, X-Ray, Stationary
Philips Healthcare Inc.
Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.
| Date | Mar 27, 2012 (initiated Apr 1, 2011) |
| Status | Terminated |
| Reason | It was discovered in some instances the detector did not reset as quickly as the user prompted a change form one image receptor (auxiliary) to the next, and then back again. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | An Important Electronic Product Radiation Warning letter, dated February 28, 2012, was sent to customers. The letter identified the affected product, a description of the issue, the hazard involved, along with the actions to be taken and planned. Customers were to use one of the three work-a-rounds provided. The issue will be corrected with Field Change Order 70600064, which consists of a Software Update 4.0.2SP Service Pack installed on the system. If further information or support is needed, customers can contact Dominic Siewko at 978-659-7936. |
| Quantity | 96 |
| Distribution | Worldwide Distribution - Including USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.