Z-0771-2021Class II

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

Name: Z-0771-2021 SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-11-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-11-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus on 2020-11-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0771-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-24
Posted: 2021-01-09
Terminated: 2024-02-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 3044
Distribution: US Nationwide
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0771-2021	Class II	Terminated	FDA Mandated	2021-01-20	2021-01-09

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)