Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
FDA Recall Z-1597-2018 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-01-26
Date Terminated2018-10-12
Product Quantity42 units
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.
Firm Action
Customers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall notice to the new owner.
Root Cause
Software Design Change
Distribution Pattern
Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.