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Terminated

Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: 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-1721-2014 · Posted 2014-06-04

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-03-21
Date Terminated2015-03-16
Product Quantity345

Reason for Recall

The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

Firm Action

Siemens sent a Customer Safety Advisory Notice/ Field Safety Notice letter dated March 21, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that the system modification would be implemented by Siemens service specialists in April 2014 to correct the problem.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050297SOMATOM EMOTION 16Siemens Medical Solution, Inc. USA · 2005-03-01K042328SOMATOM SPIRITSiemens Medical Systems, Inc. · 2004-09-14K023687SOMATOM EMOTION 6 CT SYSTEMSSiemens Medical Systems, Inc. · 2002-11-22

Official Source

View FDA Recall →

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

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