Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 10/7/2020
Class II
PRODUCT
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
Recall Number: Z-3025-2020
REASON
Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 6/22/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
728 distributed in U.S.
DISTRIBUTION
U.S. Nationwide