Siemens Biograph PET/CT Scanner Recall for Calibration Error Risk
Siemens is recalling Biograph 6 TP scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential for unexpected values without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling the Biograph 6 TP 3R to 4R Upgrade (Material Number 10246387). The affected product is a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. The recall is limited to one unit with Serial Number 45646, which was distributed worldwide and in the US nationwide.
The recall was initiated because Siemens Medical Solutions, Molecular Imaging became aware of a potential for unexpected Standardized Uptake Value (SUV) values if a non-Siemens phantom is used for calibration. This issue could affect the accuracy of the scanner's measurements.
Healthcare facilities and users of the affected scanner should contact Siemens Medical Solutions USA Inc. for further instructions on how to proceed with the recall and to ensure proper calibration protocols are followed.
The recalled product
- Product
- Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informat
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 1
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 (1)
- Serial Number 45646
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by Siemens Medical Solutions USA Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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