Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Reported: May 9, 2018 Initiated: January 26, 2018 #Z-1597-2018
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 42 units
- Distribution
- Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
- Location
- Hoffman Estates, IL
Frequently Asked Questions
What product was recalled? ▼
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 42 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1597-2018.
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