Z-1508-2021 Class II Ongoing
FDA device recall Z-1508-2021 was initiated by CHANGE HEALTHCARE CANADA COMPANY on March 17, 2021 and is designated Class II. Reason for recall: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. The recall status is ongoing. Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 17, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
Change Healthcare Enterprise Viewer
Reason for Recall
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Distribution Pattern
Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA
Code Information
Change Healthcare Enterprise Viewer 2.0 and 2.1