FDAClass IIOctober 14, 2020

Change Healthcare Radiology Solutions 14.0 recall: Software Issue

Change Healthcare Radiology Solutions 14.0

Why was Change Healthcare Radiology Solutions 14.0 recalled?

Software defect which may potentially result in one or more images missing in a study

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?

All Model number 14.0 UDI (01)17540262030020(10)140000

Product
Change Healthcare Radiology Solutions 14.0
Recalling firm
CHANGE HEALTHCARE CANADA COMPANY
Quantity
5 devices
Distribution
Domestic distribution to VT, MS, WV, NE
Recall date
October 14, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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