Z-2334-2015Class II

SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

Name: Z-2334-2015 SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
Creator: Siemens Medical Solutions USA Inc.
Published: 2015-07-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-07-14 / Terminated / root cause: packaging

FDA source

Siemens Medical Solutions USA Inc. began a recall of SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 on 2015-07-14. FDA classified it as Class II and gives the reason as "Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2334-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-14
Posted: 2015-08-05
Terminated: 2016-03-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015.
Quantity in commerce: 1 unit
Distribution: Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
Product codes and lots: SERIAL NUMBER 11004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2334-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2332-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2333-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2334-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2335-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2336-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2337-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05
Z-2338-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-05

Product code KPS

K123737Class IIBiograph Mct FamilySiemens Medical Solutions USA, Inc. / cleared 2013-01-29

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)