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Terminated

SOMATOM Emotion 16; 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-1933-2015 · Posted 2015-06-27

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-06-04
Date Terminated2017-03-24
Product Quantity40 total

Reason for Recall

A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

Firm Action

A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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