Z-2401-2019Class II

SOMATOM go.Up; Models ##11061628

Name: Z-2401-2019 SOMATOM go.Up; Models ##11061628
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-31 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by... on 2019-07-31. FDA classified it as Class II and gives the reason as "The injector holder could potentially fall off together with the injector and the storage box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-31
Posted: 2019-08-28
Terminated: 2020-12-02
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM go.Up; Models ##11061628 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
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The injector holder could potentially fall off together with the injector and the storage box.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 1. Take special care when rotating the injector and storage box horizontally 2. Your Siemens Healthineers service engineer will perform an on-site check to evaluate the stability of the injector arm. 3. If there is any problem with the injector arm, your Siemens Healthineers service engineer will replace the injector arm with an improved intermediate version free of charge. 4. Please ensure all users of the affected products are aware. 5. Retain this notification in your product related records and place a copy in the medical device's instructions for use. 6. If you have distributed this product, identify your customers and notify them. If you wish to request an earlier appointment or have additional questions, feel free to contact service organization at 1-800-888-7436 .
Quantity in commerce: 3 units
Distribution: US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD
Product codes and lots: Serial Number 108183 108177 108176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2401-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2399-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2400-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2401-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2402-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2403-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2404-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27
Z-2405-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

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)