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SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of th...

FDA Recall #Z-0971-2015 — Class II — December 3, 2014

Recall #Z-0971-2015 Date: December 3, 2014 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

Artifacts are found in acquired imaging on the SOMATOM Force.

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7

Distribution

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

Code Information

Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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