Z-1773-2021 Class II Ongoing
FDA device recall Z-1773-2021 was initiated by CHANGE HEALTHCARE CANADA COMPANY on April 19, 2021 and is designated Class II. Reason for recall: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. The recall status is ongoing. Affected quantity: 33 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 devices
Product Description
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 medical images, reports, and multimedia content.
Reason for Recall
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Distribution Pattern
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.
Code Information
Software version 2.0 and 2.1.