Z-1997-2016Class II

BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786

Name: Z-1997-2016 BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786
Creator: Siemens Medical Solutions USA Inc.
Published: 2016-04-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-04-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA Inc. began a recall of BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron... on 2016-04-25. FDA classified it as Class II and gives the reason as "The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1997-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-25
Posted: 2016-06-15
Terminated: 2017-02-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: 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: The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative.
Quantity in commerce: 1 unit
Distribution: Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Product codes and lots: Serial Number 21139

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1997-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1997-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15
Z-1998-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15
Z-1999-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15
Z-2000-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15

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)