Data Foundry

Medical device recalls 2015

SOMATOM Force — Class II medical device recall Z-0971-2015

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-01-21, distributed in MA, MD, MN, PA, SC, TX. Artifacts are found in acquired imaging on the SOMATOM Force.

Recall numberZ-0971-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2014-12-03
Classified2015-01-14
Reported by FDA2015-01-21
Terminated2015-04-06
DistributedMA, MD, MN, PA, SC, TX
Quantity7
Serial numbers75437, 75439, 75450, 75454, 75464, 75467, 75475
Model numbers10742326

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0971-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.