FDAClass IIOctober 2, 2019

DigitalDiagnost C50 recall

DigitalDiagnost C50, Stationary X-ray System

Why was DigitalDiagnost C50 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number 712201 System Serial Number: SN170053 SN180074

Product
DigitalDiagnost C50, Stationary X-ray System
Recalling firm
Philips Healthcare
Quantity
2
Distribution
Puerto Rico
Recall date
October 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls