Siemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error
Siemens is recalling 47 Biograph mCT-S 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 diagnostic errors (unexpected SUV values) rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 47 units of the Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668. 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 were distributed worldwide and nationwide in the US.
Healthcare facilities should contact Siemens Medical Solutions USA Inc. for instructions on how to address the calibration issue. The specific serial numbers affected are listed in the agency's recall record.
The recalled product
- Product
- Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 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
- 47
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: 1002
- 1004
- 1006
- 1007
- 1005
- 1010
- 1013
- 1016
- 1017
- 11018
- 11019
- 11031
- 1012
- 11020
- 1014
- 11026
- 11022
- 1015
- 11024
- 11025
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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