FDA Enforcement
Class II
Ongoing
Change Healthcare Enterprise Viewer
Recall: Z-1508-2021
·
Reported May 5, 2021
Enforcement
- Recall Number
- Z-1508-2021
- Event ID
- 87616
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CHANGE HEALTHCARE CANADA COMPANY
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 5, 2021
- Initiation Date
- March 17, 2021
- Classification Date
- April 28, 2021
- Address
- 10711 Cambie Rd Suite 130, N/A, Richmond, N/A, N/A, Canada
Description
Change Healthcare Enterprise Viewer
Reason
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Code Info
Change Healthcare Enterprise Viewer 2.0 and 2.1
Distribution
Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA
Quantity
28 units