Recall Z-2498-2019 ยท KPR System, X-Ray, Stationary
Philips Healthcare
DigitalDiagnost C50, Stationary X-ray System
| Date | Dec 21, 2018 |
| Status | Terminated |
| Reason | During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected product, the actions you are required to take and the actions planned by Philips to correct the issue. If you need any or further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips plans to initiate a field corrective action that will install the required label(s). Philips will implement the correction at no cost to the customer. |
| Quantity | 2 |
| Distribution | Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163410 | DigitalDiagnost C50 Philips Healthcare (Suzhou) Co., Ltd., Jan 4, 2017 |