Z-1645-2015Class II

SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body...

Name: Z-1645-2015 SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-04-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-04-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission... on 2015-04-20. FDA classified it as Class II and gives the reason as "Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo...". 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-1645-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Posted: 2015-05-22
Terminated: 2016-09-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM Emotion 16, the intended use of computed tomography is 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 angels or spiral planes taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.
Quantity in commerce: 75
Distribution: Nationwide Distribution including Puerto Rico.
Product codes and lots: SOMATOM Emotion 16 (2007) 10165977 with serial numbers: 86514 32490 80553 32552 32530 86406 86558 80542 80461 86405 32512 80441 86431 80467 86425 80442 86429 86557 80434 32581 32637 32597 80448 80431 32624 32469 80446 32578 80430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1645-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1644-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-22
Z-1645-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-22
Z-1646-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-22

Product code JAK

K133424Class IISomatom Emotion 6 CT Systems, Somatom Emotion 16Siemens Medical Solutions USA, Inc. / cleared 2014-01-17

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)