Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synaptive ImageDrive Clinical Recalled by Synaptive Medical Inc Due to A software defect negatively affects the quality of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synaptive Medical Inc directly.
Affected Products
Synaptive ImageDrive Clinical
Quantity: 28 units
Why Was This Recalled?
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Where Was This Sold?
US
About Synaptive Medical Inc
Synaptive Medical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report