Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error
Siemens is recalling two Biograph TruePoint PET/CT 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 hazard is a potential for unexpected calibration values without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling two units of the SYS IVK, Bio mCT-X 3R->4R Upgrade (Material Number 10250745) for Siemens Biograph TruePoint systems. These are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used to provide registration and fusion of high-resolution physiologic and anatomic information.
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 affected units have serial numbers 1001 and 1002 and were distributed worldwide, including nationwide in the United States.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 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 infor
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 2
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)
- Serial Numbers: 1001
- 1002
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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