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Synaptive Medical Inc recalls Synaptive ImageDrive Clinical
Recalled April 29, 2020 · FDA recall Z-1759-2020 · Synaptive Medical
Hazard
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. · FDA Class II
Units
28 units
Sold at
US
Description
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Product
Synaptive ImageDrive Clinical
Manufacturer(s)
Synaptive Medical Inc
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →