medical Class II Updated 2018-05-09

Siemens Medical Solutions USA, Inc. recalls Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version VJ20A. Code No. 10532746, 10532748.
View official government recall

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