FDAFDA · Food and drugs·Recall number Z-1773-2021
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.
Published June 9, 2021 · Recall initiated: April 19, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Distributor
- 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.
- Lot
- Software version 2.0 and 2.1.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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