Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 46 Biograph 40 TruePoint PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used 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, but the hazard is a potential for inaccurate calibration values rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 46 units of the BIOGRAPH 40 TruePoint w/TrueV (Material Number 10097304) combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The recall is due to a potential for unexpected Standardized Uptake Value (SUV) values if a non-Siemens phantom is used for calibration.
The affected units were distributed worldwide and across the United States. The recall covers specific serial numbers ranging from 1001 to 1053, with certain numbers excluded as listed in the official record.
Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the calibration issue to ensure accurate imaging results.
The recalled product
- Product
- BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 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 information
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 46
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 (20)
- Serial Numbers: 1001
- 1002
- 1003
- 1004
- 1005
- 1006
- 1007
- 1008
- 1009
- 1010
- 1011
- 1012
- 1013
- 1014
- 1015
- 1016
- 1017
- 1018
- 1019
- 1021
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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