RecallRadar

FDA Device recall Z-1267-2015

SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0

On 2015-03-18 the FDA classified a Class II recall of SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0 by Siemens Medical Solutions Usa, citing 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,….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1267-2015
ClassificationClass II
Statusterminated
Initiated2015-02-06
Published2015-03-18
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

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

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.

Identifiers

code_infoModel number: 10742326, with serial numbers: 75454, 75464, 75437, 75475, 75481, 75439, 75450, 75460, 75476, 75458, 75467, 75478.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2015%22

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