ClearanceBrief
Recall Z-0406-2020 ยท JAK System, X-Ray, Tomography, Computed

Siemens Medical Solutions USA, Inc

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

DateOct 7, 2019
StatusTerminated
ReasonSoftware issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Root causeSoftware design
ActionSiemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice (CSAN) to all affected customers via CT070/19/S. on 10/719 via email/or letter. The CSAN provides recommendations to avoid the issues until the technical solution can be applied. The issues will be resolved with software update version syngo CT VB20_SP1 (Service Pack 1). You will receive the updated software free of charge. Questions or require technical support, please contact the service organization at 1-800-888-7436.
Quantity305 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K103127SOMATOM DEFINITION AS
Siemens Medical Solutions USA, Inc., Mar 4, 2011
K121072SOMATOM DEFINITION FLASH
Siemens Medical Systems, Inc., May 8, 2012
K133589SOMATOM FORCE
Siemens Medical Solutions USA, Inc., Apr 17, 2014
K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open,
Siemens Medical Solutions USA, Inc., Nov 24, 2015
K161196SOMATOM Drive
Siemens Medical Solutions USA, Inc., Aug 24, 2016
K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Dei
Siemens Medical Solutions USA, Inc., Mar 30, 2018