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Terminated

SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.

FDA Recall Z-1558-2016 · Posted 2016-04-22

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-04-01
Date Terminated2017-04-17
Product Quantity37 CTsystems

Reason for Recall

The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.

Firm Action

Siemens distributed a Safety Advisory Notice dated April 1, 2016, to affected customers The letter identified the affected product, problem, how to avoid potential risks, how the issue will be resolved. and actions to be taken. Customers were asked to observe the safety notice and comply with the corresponding measures until further notice.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA

Official Source

View FDA Recall →

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

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