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Z-0406-2020Class II

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model...

Siemens Medical Solutions USA, Inc. / initiated 2019-10-07 / Terminated / root cause: software
FDA source (opens on fda.gov)

Siemens Medical Solutions USA, Inc began a recall of Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027)... on . FDA classified it as Class II and gives the reason as "Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0406-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
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
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
Root cause tag
software
FDA root cause
Software design
Action
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.
Quantity in commerce
305 units
Distribution
Nationwide
Product codes and lots
Software versions syngo CT VB20

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0406-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0406-2020Class IITerminatedVoluntary: Firm initiated