Z-1597-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- January 26, 2018
- Termination Date
- October 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
Product Description
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
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.
Distribution Pattern
Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
Code Information
Software version VJ20A. Code No. 10532746, 10532748.