Recall Z-1759-2020 ยท LLZ System, Image Processing, Radiological
Synaptive Medical Inc
Synaptive ImageDrive Clinical
| Date | Feb 26, 2020 |
| Status | Terminated |
| Reason | A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated this field corrective action by letter on 02/26/2020. The consignees are not required to discontinue using the device nor return the device to Synaptive Medical, a workaround is to be followed as indicated in the customer notification letter. The actions to be taken by consignees with the affected product are as follows: 1. Acknowledge receipt of the notification using the acknowledgment and receipt form that the firm has provided. 2. a) If ClearCanvas Workstation is NOT used for viewing images on removeable media such as CDs, and this issue is encountered, configure the P |
| Quantity | 28 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153284 | Synaptive ImageDrive Pro Synaptive Medical, Inc., Mar 29, 2016 |