Medical device recalls Moderate risk

Philips Healthcare recalls DigitalDiagnost C50, Stationary X-ray System

Recall date
December 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2498-2019
FDA classification
Class II
Brand / firm
Philips Healthcare
Sold / distributed
Puerto Rico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DigitalDiagnost C50, Stationary X-ray System

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