Z-1350-2016Class II

SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by...

Name: Z-1350-2016 SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-03-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-03-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from... on 2016-03-22. FDA classified it as Class II and gives the reason as "Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened...". 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-1350-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-22
Posted: 2016-04-08
Terminated: 2017-08-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation
Root cause tag: manufacturing process
FDA root cause: Other
Action: Siemens sent an "Informational Only" notice to customers on 03/22/2016 informing them to be aware that the front cover on some Siemens CT systems was not properly welded. The letter was only to notify customers that the issue is being addressed with the completion of a service visit. In addition, Siemen plans to replace each cover and hand delivered each notification to customers at the time the service is performed.
Quantity in commerce: 1 CT system
Distribution: Distributed to: Cincinnati, OH.
Product codes and lots: Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1350-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08

Product code JAK

K143400Class IISOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. / cleared 2015-04-08

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)