Z-1758-2020 Class II Terminated
FDA device recall Z-1758-2020 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: 903 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
- 903 units
Product Description
ClearCanvas RIS/PACS
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
ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1