Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/9/2018
Class II:

PRODUCT
Biograph Horizon – PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Recall Number: Z-15972018

REASON
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.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Hoffman Estates, IL on 1/26/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
42 units

DISTRIBUTION
Nationwide and internationally