Recall Z-1696-2016 ยท KPR System, X-Ray, Stationary
Philips Healthcare
Philips Healthcare DuraDiagnost stationary X-ray system
| Date | Jun 3, 2016 (initiated Nov 10, 2015) |
| Status | Terminated |
| Reason | The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377. |
| Quantity | 5 |
| Distribution | USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141381 | DURADIAGNOST Philips Healthcare (Suzhou) Co., Ltd., Jun 12, 2014 |