Synaptive Medical Inc recalls Synaptive ImageDrive Clinical
- Recall date
- February 26, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1759-2020
- FDA classification
- Class II
- Brand / firm
- Synaptive Medical Inc
- Sold / distributed
- US
Why it was recalled
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Synaptive ImageDrive Clinical
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