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Recall Observatory FDA recall evidence

Device product

DigitalDiagnost C50, Stationary X-ray System

Z-2498-2019

December 21, 2018

Class II

Product summary

Firm
Philips Healthcare
Event
Event 83654
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2498-2019

Official wording

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 information: Product Number 712201 System Serial Number: SN170053 SN180074

Distribution pattern: Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    missing label