SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
FDA Recall Z-1246-2019 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-02-14
Date Terminated2020-05-01
Product Quantity53 total units distributed in U.S.
Reason for Recall
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
Firm Action
Siemens issued letter dated 2/14/19 providing reason for recall and a user workaround in the Customer Safety Advisory Notice (CSAN) CT006/19/S. The recall issue will be permanently resolved by software update syngo CT VB10A_SP1. Contact the service organization 1-800-888-7436.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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