RecallRadar

FDA Device recall Z-1915-2019

SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system…

On 2019-07-10 the FDA classified a Class II recall of SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system… by Siemens Medical Solutions Usa, citing the potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1915-2019
ClassificationClass II
Statusterminated
Initiated2019-05-28
Published2019-07-10
Last updated2026-09-13 11:55 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

Reason

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

Identifiers

code_infoSerial Number: 112552 112551 112555 112519 112542 112545 112541 112536 112573

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1915-2019%22

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