Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1597-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 26, 2018

Date Posted: May 9, 2018

Recall Number: Z-1597-2018

Event ID: 79988

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.

Status: Terminated

Product Quantity: 42 units

Code Information:

Software version VJ20A. Code No. 10532746, 10532748.

Distribution Pattern:

Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated