Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 11/20/2019
Class II
PRODUCT
Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. 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), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20
- Recall Number: Z-0406-2020
REASON
Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 8/30/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
305 units
DISTRIBUTION
Nationwide