ClearCanvas RIS/PACS
This recall has been terminated (originally issued February 26, 2020).
- Company
- Synaptive Medical Inc
- Recall Initiated
- February 26, 2020
- Terminated
- April 10, 2024
- Recall Number
- Z-1758-2020
- Quantity
- 903 units
- Official Source
- View on FDA website ↗
Reason for Recall
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Distribution
US
Lot / Code Info
ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1
Root Cause
Under Investigation by firm
Action Taken
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 PACS or DICOM device that is sending images to ClearCanvas Workstation to send uncompressed images, or images compressed with a compression algorithm other than JPEG 2000. b.) If ClearCanvas Workstation IS used for viewing images on removeable media such as CDs OR if it is not possible to change the sending device to send uncompressed images, contact Synaptives Product Support Recall Line at 1.866.853.8001 to request assistance to correct the device. Note that if the software is subsequently re-installed, the device will need to be corrected again. Contact Synaptive to repeat the correction.