Z-1918-2019Class II

SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1

Name: Z-1918-2019 SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-05-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-05-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to... on 2019-05-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1918-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2019-07-02
Terminated: 2023-03-31
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM go.Top (Model #1161640), 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters dated 5/24/19 were sent to customers.
Quantity in commerce: 30
Distribution: US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.
Product codes and lots: Serial Number: 119103 119090 119098 119086 119081 119115 119125 119145 119148 119119 119132 119123 119133 119084 119085 119088 119087 119141 119083 119143 119153 119122 119120 119093 119109 119111 119144 119152 119142 119147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1918-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1915-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1916-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1917-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1918-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02

Product code JAK

K173632Class IISOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. / cleared 2018-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)