Z-1930-2018Class II

Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of...

Name: Z-1930-2018 Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2018-02-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-02-21 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information on 2018-02-21. FDA classified it as Class II and gives the reason as "Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal...". 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-1930-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-21
Posted: 2018-05-24
Terminated: 2018-10-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Customers were notified via letter on approximately 02/21/2018. Letters were sent via certified mail or email. Instructions included to discontinue use of the system (according to the cardiac imaging protocols listed in the letter), ensure the customer advisory notice is placed in the Biograph Horizon Operator's Manual, ensure the recall information is disseminated to all operators of the system, coordinate the installation of the updated Universal Physiological Measurement Module with Siemens Healthineers, and if the equipment has been sold to forward the letter to the new owner.
Quantity in commerce: 14 units
Distribution: Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Product codes and lots: Code No. 10532746, 10532748

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1930-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1930-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-24

Product code KPS

K170904Class IIBiograph Horizon PET/CTSiemens Medical Solutions USA, Inc. / cleared 2017-06-01

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)