FDA Enforcement
Class II
Terminated
DigitalDiagnost C50, Stationary X-ray System
Recall: Z-2498-2019
·
Reported October 2, 2019
Enforcement
- Recall Number
- Z-2498-2019
- Event ID
- 83654
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Healthcare
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- October 2, 2019
- Initiation Date
- December 21, 2018
- Classification Date
- September 20, 2019
- Termination Date
- October 27, 2020
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032, United States
Description
DigitalDiagnost C50, Stationary X-ray System
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.
Code Info
Product Number 712201 System Serial Number: SN170053 SN180074
Distribution
Puerto Rico
Quantity
2