FDA-Device2019-10-02Class II

DigitalDiagnost C50, Stationary X-ray System

Philips Healthcare
Hazard

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.

Sold states
Puerto Rico
Affected count
2
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
DigitalDiagnost C50, Stationary X-ray System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2019

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