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Terminated

SOMATOM Force; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.

FDA Recall Z-0971-2015 · Posted 2015-01-14

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-12-03
Date Terminated2015-04-06
Product Quantity7

Reason for Recall

Artifacts are found in acquired imaging on the SOMATOM Force.

Firm Action

A customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

PA, MA, MN, SC, MD, and TX.

Official Source

View FDA Recall →

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

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