FDA-Device2018-05-09Class II
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Siemens Medical Solutions USA, Inc.
Hazard
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.
Sold states
Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
Affected count
42 units
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2018Don't want to check this manually?
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