FDA-Device2020-04-29Class II
Synaptive ImageDrive Clinical
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
28 units
Manufactured in
555 Richmond St West, Suite 800, N/A, Toronto, N/A, Canada
Products
Synaptive ImageDrive Clinical
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1759-2020Don't want to check this manually?
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