Synaptive ImageDrive Clinical recall: Software Issue
Synaptive ImageDrive Clinical
Why was Synaptive ImageDrive Clinical recalled?
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1
- Product
- Synaptive ImageDrive Clinical
- Recalling firm
- Synaptive Medical Inc
- Quantity
- 28 units
- Distribution
- US
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)