Z-1920-2019Class II

SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1

Name: Z-1920-2019 SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-06-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-06-04 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to... on 2019-06-04. FDA classified it as Class II and gives the reason as "The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan". 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-1920-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-04
Posted: 2019-07-02
Terminated: 2023-03-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM go.Now, Model No. 11061618 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 cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Root cause tag: software
FDA root cause: Software design
Action: On June 4, 2019, the firm notified customers of the recall via Urgent Medical Device Correction letters. Customers were informed that the firm has developed software update CT VA20A-SP2A to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also improve some areas during the start-up and shut-down processes, as well as providing other improvements related to the system, examination and reconstruction processes, and dual energy and intervention . The corrective action will be provided free of charge and will be distributed via Update Instruction CT026/19P. This update will be performed remotely. If you have any questions, please contact our service organization at 1- 800-888-7436. Customers were asked to promptly notify and instruct all staff at their organizations who need to be aware of this notice. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product advisory notice. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner.
Quantity in commerce: 69
Distribution: US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI
Product codes and lots: 106527 106565 106456 106464 106545 106237 106375 106526 106484 106562 106400 106260 106459 106150 106593 106133 106115 106360

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1920-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1919-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1920-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1921-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-02
Z-1922-2019	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)