RecallRadar

FDA Device recall Z-0948-2013

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system

On 2013-03-20 the FDA classified a Class II recall of Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system by Siemens Medical Solutions Usa, citing sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0948-2013
ClassificationClass II
Statusterminated
Initiated2012-11-27
Published2013-03-20
Last updated2026-09-13 11:53 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

Reason

Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

Identifiers

code_infoModel numbers - 7740769, 8098027, 10430603, and 10590000.

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-0948-2013%22

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