Z-1759-2020 Class II Terminated
FDA device recall Z-1759-2020 was initiated by Synaptive Medical Inc on February 26, 2020 and is designated Class II. Reason for recall: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. The recall status is terminated (terminated April 10, 2024). Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- February 26, 2020
- Termination Date
- April 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
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 Pattern
US
Code Information
ImageDrive Clinical with part number SYN-0578- all versions of the software. With unique device identifier (UDI) #(01) 00670082000139 (10)13x1