FDA recall Z-1597-2018

Siemens Medical Solutions USA, Inc. · Class II · device

Product

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

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2018-01-26
Report date: 2018-05-09
Termination date: 2018-10-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hoffman Estates, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2018