Z-1301-2016Class II

Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce...

Name: Z-1301-2016 Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-15 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction... on 2016-02-15. FDA classified it as Class II and gives the reason as "Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1301-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-15
Posted: 2016-03-31
Terminated: 2016-12-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data 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 is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
Root cause tag: design
FDA root cause: Device Design
Action: A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
Quantity in commerce: 124 units
Distribution: US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.
Product codes and lots: Model Number: SOMATOM Emotion 16 - 7734713

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1301-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1300-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1301-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1302-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1303-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1304-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1305-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1306-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1307-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

Product code JAK

K050297Class IISomatom Emotion 16Siemens Medical Solution, Inc. USA / cleared 2005-03-01

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)