Siemens Biograph 40 PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling five Biograph 40 PET/CT scanners due to a potential for unexpected Standardized Uptake Value (SUV) readings when non-Siemens phantoms are 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 source text describes a potential for unexpected values rather than reported injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling five units of the BIOGRAPH 40 - 3 Ring PET/CT scanners (Material Number 10097233). The affected serial numbers are 1001, 1004, 1009, 1012, and 1014. These systems 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 agency has classified this as a Class II recall. The affected units were distributed worldwide and across the United States.
Healthcare facilities that possess these specific serial numbers should contact Siemens Medical Solutions USA Inc. for further instructions on how to address the calibration issue. No specific instructions for end-users are provided in the source text, as the product is a medical device intended for professional use.
The recalled product
- Product
- BIOGRAPH 40 - 3 Ring, Material Number 10097233 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
- 5
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 (5)
- Serial Numbers: 1001
- 1004
- 1009
- 1012
- 1014
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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