Z-0807-2015Class II

Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined...

Name: Z-0807-2015 Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined...
Creator: Siemens Medical Solutions USA Inc.
Published: 2014-11-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-11-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA Inc. began a recall of Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission... on 2014-11-13. FDA classified it as Class II and gives the reason as "Possibility for system display freeze during CT interventional procedures". 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-0807-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Posted: 2014-12-16
Terminated: 2015-07-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Possibility for system display freeze during CT interventional procedures.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated their recall by certified mail on 11/13/2014.
Quantity in commerce: 4 units
Distribution: Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
Product codes and lots: Serial Numbers: 11002, 11005, 11006, 11008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0807-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0807-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16
Z-0808-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16
Z-0809-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16
Z-0810-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16
Z-0811-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

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)