—#185207

Product

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103127, K121072, K133589, K142955, K161196, K173607
Affected lot / code info: 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) Siemens SOMATOM CT scanner systems with software syngo.CT VB20A_SP2.

Why it was recalled

System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

Root cause (FDA determination)

Software design

Action the firm took

Customer notification letters will be sent starting December 14, 2020 to all affected customers via Customer Advisory Notice CT057/20/S. The technical solution, software versionVB20A_SP3, will be distributed to all affected customers free of charge via CT056/20/S. For questions or technical support, contact your local application specialists or your local service/sales organization at 1-800-888-7436.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2020-11-24
Terminated: 2024-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.