Z-1758-2020Class II

ClearCanvas RIS/PACS

Name: Z-1758-2020 ClearCanvas RIS/PACS
Creator: Synaptive Medical Inc
Published: 2020-02-26
License: https://open.fda.gov/license/

Synaptive Medical Inc / initiated 2020-02-26 / Terminated / root cause: software

FDA source

Synaptive Medical Inc began a recall of ClearCanvas RIS/PACS on 2020-02-26. FDA classified it as Class II and gives the reason as "A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1758-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-26
Posted: 2020-04-22
Terminated: 2024-04-10
Recalling firm: Synaptive Medical Inc
Product: ClearCanvas RIS/PACS
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Root cause tag: software
FDA 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 in commerce: 903 units
Distribution: US
Product codes and lots: ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1758-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1758-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-22
Z-1759-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-22

Product code LLZ

K110332Class IIClearcanvas Ris / PacsClearcanvas, Inc. / cleared 2011-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)