Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error
Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT 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, and the hazard involves potential measurement inaccuracy (unexpected SUV values) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 100 units of the Biograph mCT-S(40) 4R, a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. The recall is due to a potential for unexpected Standardized Uptake Value (SUV) readings if a non-Siemens phantom is used for the device's calibration.
The affected units are distributed worldwide and across the United States. The recall covers specific serial numbers listed in the agency's official documentation. The hazard is limited to the accuracy of the calibration process when third-party equipment is utilized.
Healthcare facilities and users of these devices should verify their calibration procedures to ensure that only approved Siemens phantoms are used to maintain accurate SUV values.
The recalled product
- Product
- Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 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.
- Affected units
- 100
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: 1024
- 1001
- 1002
- 1003
- 1005
- 1006
- 1007
- 1008
- 1009
- 1011
- 1012
- 1013
- 1004
- 1014
- 1017
- 1018
- 1019
- 1020
- 1022
- 1010
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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