Z-0373-2017Class II

SOMATOM Definition AS system, x-ray, tomography, computed

Name: Z-0373-2017 SOMATOM Definition AS system, x-ray, tomography, computed
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-10-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-10-19 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition AS system, x-ray, tomography, computed on 2016-10-19. FDA classified it as Class II and gives the reason as "Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts". 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-0373-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-19
Posted: 2016-11-08
Terminated: 2017-03-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition AS system, x-ray, tomography, computed
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens mailed a Customer Safety Advisory Notice to affected customers on October 19, 2016, to inform them about the hardware issue. The notice provided guidance on risk prevention and actions they are taking to develop a solution to correct the issue. For further questions, please call (610) 448-6471.
Quantity in commerce: 57 systems distributed in USA
Distribution: Nationwide Distribution
Product codes and lots: Model Numbers: 8098027 10430603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0373-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0373-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08
Z-0374-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08

Product code JAK

K143409Class IISOMATOM Definition AS Open (VA48)Siemens Medical Solutions USA, Inc. / cleared 2015-03-26

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)