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Recall Observatory FDA recall evidence

Device product

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

Z-1597-2018

January 26, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc.
Event
Event 79988
Status
Terminated
Classification
Class II
Quantity
42 units
Official record key
device-enforcement:Z-1597-2018

Official wording

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.

Code information: Software version VJ20A. Code No. 10532746, 10532748.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.