DigitalDiagnost C50, Stationary X-ray System
FDA Recall #Z-2498-2019 — Class II — December 21, 2018
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.
Recalling Firm
Philips Healthcare — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2
Distribution
Puerto Rico
Code Information
Product Number 712201 System Serial Number: SN170053 SN180074
Status
Terminated
Voluntary / Mandated
FDA Mandated