Reported Jun 9, 2021 · Ongoing
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D…
Change Healthcare Canada Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CHANGE HEALTHCARE CANADA COMPANY · 10711 Cambie Rd Suite 130 · Richmond · N/A
Is this the product you have?
- Change Healthcare
- Enterprise Viewer - Product Usageintended 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
- Lot codes and dates
- Software version 2.0 and 2.1.
- Amount recalled
- 33 devices
Where it was sold
Why it was recalled
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
This product could cause temporary or reversible health problems — stop using it.
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