FDA Medical Device Recalls (openFDA)
Synaptive Medical Inc: ClearCanvas RIS/PACS
- Recall number
- Z-1758-2020
- Recalling firm
- Synaptive Medical Inc
- Product
- ClearCanvas RIS/PACS
- Status
- Terminated
- Initiated
- 2020-02-26
- Posted
- not on file
- Terminated
- 2024-04-10
- 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 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.
- Quantity
- 903 units
- Distribution
- US
- Lot, serial or model codes
- ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1
- 510(k) numbers
- ["K110332"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3012075008
- Firm city
- Toronto
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28