FDA recall Z-1773-2021

CHANGE HEALTHCARE CANADA COMPANY · Class II · device

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 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

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.

Key facts

Status
Ongoing
Initiation date
2021-04-19
Report date
2021-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2021