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