Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error
Siemens is recalling 16 Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
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 hazard involves potential data inaccuracy (unexpected SUV values) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity issue.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 16 units of the BIOGRAPH 64-3R TruePoint combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The affected units are identified by specific serial numbers and were distributed worldwide and nationwide in the US.
The recall was initiated because Siemens became aware of a potential for unexpected Standardized Uptake Value (SUV) values if a non-Siemens phantom is used for calibration. This issue may affect the accuracy of the imaging data produced by the devices.
Healthcare facilities and users of these scanners should contact Siemens Medical Solutions for further instructions on how to address the calibration issue. The source text does not specify a remediation method or a deadline for action.
The recalled product
- Product
- BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 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.
- Affected units
- 16
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 (16)
- Serial Numbers: 1021
- 1024
- 1027
- 1029
- 1030
- 1031
- 1032
- 1033
- 1034
- 1037
- 11044
- 11045
- 11046
- 11047
- 11048
- 11049
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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