Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 12 Biograph mCT Flow 64-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
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. The hazard involves potential calibration errors leading to unexpected SUV values, which is a diagnostic accuracy issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate severity criteria for low-risk contamination or minor errors.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 12 units of the BIOGRAPH mCT Flow 64-3R, Material Number 10529160. 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 are identified by serial numbers 11001, 11002, 11003, 11006, 11004, 11007, 11008, 11009, 11005, 11010, 11011, and 11012.
The affected units were distributed worldwide and nationwide in the United States. The source text does not specify instructions for consumers or healthcare providers regarding corrective actions or next steps.
The recalled product
- Product
- BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 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
- 12
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 (12)
- Serial Numbers: 11001
- 11002
- 11003
- 11006
- 11004
- 11007
- 11008
- 11009
- 11005
- 11010
- 11011
- 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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