Z-1425-2017Class II

Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be...

Name: Z-1425-2017 Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be...
Creator: Siemens Medical Solutions USA Inc.
Published: 2017-02-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-02-20 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA Inc. began a recall of Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care... on 2017-02-20. FDA classified it as Class II and gives the reason as "The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1425-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-02-28
Terminated: 2017-09-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.
Quantity in commerce: 4 units
Distribution: Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
Product codes and lots: 72484, 72490, 72516, 72536

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1425-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1422-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1423-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1424-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1425-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09

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)