Data Foundry

Medical device recalls 2015

SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1… — Class II medical device recall Z-1267-2015

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-03-18, distributed nationwide. Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and H

Recall numberZ-1267-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2015-02-06
Classified2015-03-12
Reported by FDA2015-03-18
Terminated2015-08-31
DistributedNationwide (US)
Quantity12
Serial numbers75437, 75439, 75450, 75454, 75458, 75460, 75464, 75467, 75475, 75476, 75478, 75481
Model numbers10742326

Product

SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: 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

Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.

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-1267-2015. 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.