FDAClass IIMay 5, 2021

Change Healthcare Enterprise Viewer recall: Software Issue

Change Healthcare Enterprise Viewer

Why was Change Healthcare Enterprise Viewer recalled?

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Change Healthcare Enterprise Viewer 2.0 and 2.1

Product
Change Healthcare Enterprise Viewer
Recalling firm
CHANGE HEALTHCARE CANADA COMPANY
Quantity
28 units
Distribution
Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA
Recall date
May 5, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls