Siemens Biograph Horizon PET/CT Scanner Software Recall for Image Errors
Siemens Medical Solutions is recalling 42 Biograph Horizon PET/CT scanners due to a software error that causes incorrect image reconstruction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that affects diagnostic image accuracy, posing a risk of harm through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 42 units of the Biograph Horizon PET/CT scanner equipped with PETsyngo VJ20A software. The recall covers units distributed worldwide, including the United States, Australia, France, India, Japan, and the Netherlands.
The recall is due to an error in the VJ20A software where array values are indexed improperly when the norm file is created during quality control. This causes incorrect values to be applied during data reconstruction, which can lead to a gradient in the PET images. The severity of the error depends on the positioning of the PET QC phantom relative to the center of the field of view.
Healthcare facilities using these scanners should contact Siemens Medical Solutions for further instructions on how to address the software error.
The recalled product
- Product
- Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software version VJ20A. Code No. 10532746
- 10532748.
Distribution
Distributed nationwide across the United States.
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