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Terminated

Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.

FDA Recall Z-0907-2014 · Posted 2014-02-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-11-15
Date Terminated2015-03-10
Product Quantity147

Reason for Recall

During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

Firm Action

A recall notification letter, dated November 15, 2013, was sent to Users.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122471SOMATOM DEFINITIONSiemens Medical Systems, Inc. · 2012-09-11K120579SOMATOM DEFINITION EDGESiemens Medical Systems, Inc. · 2012-05-23K113342SOMATOM DEFINITION FLASHSiemens Medical Systems, Inc. · 2011-12-29K103127SOMATOM DEFINITION ASSiemens Medical Solutions USA, Inc. · 2011-03-04

Official Source

View FDA Recall →

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

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