Change Healthcare Enterprise Viewer - Product Usage recall: Software Issue
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM…
Why was Change Healthcare Enterprise Viewer - Product Usage recalled?
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
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?
Software version 2.0 and 2.1.
- Product
- Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM…
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Quantity
- 33 devices
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY.
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)