Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 28 Biograph mCT Flow 20-4R 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. The hazard involves potential diagnostic inaccuracy (unexpected SUV values) rather than direct physical injury, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 28 units of the BIOGRAPH mCT Flow 20-4R, material number 10528958. These devices 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 were distributed worldwide and nationwide in the United States.
Healthcare facilities and users should contact Siemens Medical Solutions USA Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 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
- 28
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: 11001
- 11002
- 11003
- 11004
- 11005
- 11007
- 11006
- 11008
- 11009
- 11010
- 11011
- 11012
- 11013
- 11014
- 11015
- 11016
- 11017
- 11018
- 11019
- 11020
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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