Z-1597-2018Class II

Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner

Name: Z-1597-2018 Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner
Creator: Siemens Medical Solutions USA, Inc.
Published: 2018-01-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-01-26 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner on 2018-01-26. FDA classified it as Class II and gives the reason as "Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being...". 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-1597-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Posted: 2018-05-02
Terminated: 2018-10-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
Root cause tag: software
FDA root cause: Software Design Change
Action: Customers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall notice to the new owner.
Quantity in commerce: 42 units
Distribution: Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
Product codes and lots: Software version VJ20A. Code No. 10532746, 10532748.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1597-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1597-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02

Product code JAK

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)