Z-2626-2016Class II

SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

Name: Z-2626-2016 SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-07-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-07-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system on 2016-07-13. FDA classified it as Class II and gives the reason as "Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and...". 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-2626-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-13
Posted: 2016-08-23
Terminated: 2017-01-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.
Quantity in commerce: 4 systems
Distribution: Distributed to: MI, NY, CA, KY, ND, NE
Product codes and lots: Model # 8098027 Serial # 96020, 96047, 96011, and 96029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2626-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2624-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2625-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23
Z-2626-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-23

Product code JAK

K143401Class IISOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. / cleared 2015-04-06

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)