Synaptive Medical Inc: Medical Device Recall in 2020 - (Recall #: Z-1758-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ClearCanvas RIS/PACS

Product Classification:

Class II

Date Initiated: February 26, 2020

Date Posted: April 29, 2020

Recall Number: Z-1758-2020

Event ID: 85216

Reason for Recall:

A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

Status: Terminated

Product Quantity: 903 units

Code Information:

ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated