Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling Biograph 6-4R TruePoint 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 source text describes a potential for inaccurate values without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling the BIOGRAPH 6-4R TruePoint w/TrueV PET/CT scanners (Material Number 10097290). The recall affects specific serial numbers distributed worldwide and across the United States.
The recall is due to a potential for unexpected Standardized Uptake Value (SUV) readings if a non-Siemens phantom is used for system calibration. This issue may affect the accuracy of the imaging data produced by the scanners.
Healthcare facilities and users of these specific scanners should contact Siemens Medical Solutions for instructions on how to address the calibration issue. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 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 informa
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
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: 1001
- 1004
- 1015
- 1020
- 1024
- 1035
- 1042
- 44889
- 44977
- 45502
- 45509
- 45516
- 45518
- 45520
- 45522
- 45525
- 45527
- 45528
- 45532
- 45533
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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