Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles

FDA Recall Z-0608-2017 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-11-02
Date Terminated2017-11-08
Product Quantity7 systems

Reason for Recall

Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.

Firm Action

Siemens mailed a Customer Safety Notice on November 9, 2016, to customers who were affected by the recall to inform them of a possible malfunction with the systems. The notification explained the underlying issue, the effect if has on the operation of the system, potential risks involved; and the actions they plan to implement to correct the issues. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6471.

Root Cause

Software design

Distribution Pattern

Nationwide distribution to MI, NY, CA, KY, ND, and NE.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑