Company: Synaptive Medical Inc.
Date of Enforcement Report: 4/29/2020
Recall Number: Z-1758-2020
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Synaptive Medical Inc. on 2/26/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE