FDA recall Z-1759-2020
Synaptive Medical Inc · Class II · device
Product
Synaptive ImageDrive Clinical
Reason for recall
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Distribution
US
Key facts
- Status
- Terminated
- Initiation date
- 2020-02-26
- Report date
- 2020-04-29
- Termination date
- 2024-04-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Toronto, N/A, Canada
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1759-2020