Z-2498-2019 Class II Terminated
FDA device recall Z-2498-2019 was initiated by Philips Healthcare on December 21, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated October 27, 2020). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2019
- Initiation Date
- December 21, 2018
- Termination Date
- October 27, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 2
Product Description
DigitalDiagnost C50, Stationary X-ray System
Reason for Recall
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.
Distribution Pattern
Puerto Rico
Code Information
Product Number 712201 System Serial Number: SN170053 SN180074