PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 21, 2015 Initiated: December 3, 2014 #Z-0971-2015

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.

Details

Units Affected
7
Distribution
PA, MA, MN, SC, MD, and TX.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 7.
Why was this product recalled?
Artifacts are found in acquired imaging on the SOMATOM Force.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0971-2015.