Company: Synaptive Medical Inc.
Date of Enforcement Report: 4/29/2020
Class II

PRODUCT

ClearCanvas RIS/PACS

Recall Number: Z-1758-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Synaptive Medical Inc. on 2/26/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

903 units

DISTRIBUTION

US Nationwide