Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error
Siemens is recalling four Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a potential calibration error rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling four units of the BIOGRAPH Sys 40-3R to 40-4R (Material Number 10246388) PET/CT scanners. The affected serial numbers are 1001, 1003, 1010, and 11012. These systems were distributed worldwide and across the United States.
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. The source text does not report any injuries, illnesses, or deaths associated with this issue.
Healthcare facilities and users of these specific scanners should contact Siemens Medical Solutions for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 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…
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 4
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 (4)
- Serial Numbers: 1001
- 1003
- 1010
- 11012
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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