FDA-Device2020-04-29Class II
ClearCanvas RIS/PACS
Synaptive Medical Inc
Hazard
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Sold states
US
Affected count
903 units
Manufactured in
555 Richmond St West, Suite 800, N/A, Toronto, N/A, Canada
Products
ClearCanvas RIS/PACS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1758-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief