Z-1940-2018Class II

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for...

Name: Z-1940-2018 SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-04-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-04-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans on 2018-04-20. FDA classified it as Class II and gives the reason as "There is a potential for a software issue that may cause the need for necessary patient rescans". 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-1940-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-20
Posted: 2018-05-25
Terminated: 2019-05-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: There is a potential for a software issue that may cause the need for necessary patient rescans.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens Healthineers, sent an "Customer Safety Advisory Notices" letter dated 4/20/2018 beginning on 4/20/18 to its customers. The letter described the product, problem and actions to be taken. The letters provided the following information to customers: How can the operator help to avoid a potential risk of the system? To avoid an unnecessary additional X-ray dose to patients please observe the following instructions: Topic 1: If a reconstruction cannot be started after an examination, please reboot the system and repeat the aborted reconstruction. If the error persists, please contact your local Siemens Healthineers service support team. They can help you to decide whether a rescan is necessary or not. Topic 2: If you change the scan parameters kV or mA (tube HV or current), please wait for at least 12 seconds before you trigger a scan command on the control box. If artifacts are visible in the topogram, please repeat the topogram before starting the volume scan. If you have started a volume scan and detect artifacts in the real time display, please stop the scan immediately to avoid an unnecessary X-ray dose. Topic 3: After an osteoporosis scan has been completed, the Osteo reconstruction needs to be started and completed directly after the scan. Therefore the images should be loaded and checked in CT View&Go before the scan/recon tab card is closed. Please do not close the scan/recon tab card before you have reconstructed and checked all Osteo images. A successful and complete Osteo reconstruction is visualized by full green bars in the column Recon Progress of the Job Status table and by images including the Osteo phantom in the tab card CT View&Go (for details please see Fig. 3 below). An example of a correct Osteo reconstruction is provided in Fig. 2. After checking the successful and complete Osteo reconstruction you may close the scan/recon tab card. What has been done to address these issues? What actions shall be t
Quantity in commerce: 33 units in US
Distribution: Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, Indonesia, Italy, Japan, Kenya, Kuwait, Lithuania, Mauritius, Morocco, Nepal, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic Korea, Romania, Senegal, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, and United Kingdom.
Product codes and lots: Serial Numbers: 108052, 108053, 108054, 108055, 108056, 108057, 108058, 108059, 108060, 108061, 108062, 108063, 108064, 108065, 108066, 108067, 108068, 108069, 108070, 108071, 108072, 108073, 108074, 108075, 108076, 108077, 108078, 108079, 108080, 108081, 108082, 108083, 108084, 108085, 108086, 108087, 108088, 108089, 108090, 108091, 108092, 108093, 108094, 108095, 108096, 108097, 108098, 108099, 108100, 108101, 108102, 108103, 108104, 108105, 108106, 108107, 108108, 108109, 108110, 108111, 108112, 108113, 108114, 108115, 108116, 108117, 108118, 108119, 108120, 108121, 108122, 108123, 108124, 108125, 108126, 108127, 108128, 108129, 108130, 108131, 108132, 108133, 108134, 108135, 108136, 108137, 108138, 108139, 108140, 108141, 108142, 108143, 108145

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1940-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1939-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1940-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25

Product code JAK

K163296Class IISOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. / cleared 2017-03-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)