Z-2017-2016Class II

Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are...

Name: Z-2017-2016 Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are...
Creator: Siemens Medical Solutions USA Inc.
Published: 2016-04-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-04-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA Inc. began a recall of Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron... on 2016-04-22. FDA classified it as Class II and gives the reason as "Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration". 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-2017-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2016-06-21
Terminated: 2017-05-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint 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: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter.
Quantity in commerce: 2 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Serial Numbers: 72418,72428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2017-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2005-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2006-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2007-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2008-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2009-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2010-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2011-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2012-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2013-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2014-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2015-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2016-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2017-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2018-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2019-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2020-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2021-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2022-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2023-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2024-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2025-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2026-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2027-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2028-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2029-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2030-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2031-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2032-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2033-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2034-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2035-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2036-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21
Z-2037-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21

Product code KPS

K141971Class IIBiograph True Pet/ct Family SoftwareSiemens Medical Solutions USA, Inc. / cleared 2014-09-12

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)