—#177204

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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103127, K121072, K133589, K142955, K161196, K173630
Affected lot / code info: Software versions syngo CT VB20

Why it was recalled

Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

Root cause (FDA determination)

Software design

Action the firm took

Siemens 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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-10-07
Terminated: 2022-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.