Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error
Siemens is recalling five Biograph TruePoint PET/CT scanners because using a non-Siemens phantom 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, which typically corresponds to a moderate severity score. The hazard involves potential calibration errors leading to unexpected SUV values, which is a technical issue that may affect diagnostic accuracy but does not involve immediate physical injury or death.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling five units of the BIOGRAPH mCT S(20)-4R (Material Number 10534160) PET/CT scanners. The affected units have serial numbers 31001, 31002, 31003, 31004, and 60001. These systems 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 agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed worldwide and nationwide in the United States. Healthcare facilities using these scanners should contact Siemens Medical Solutions USA Inc. for further instructions on how to proceed with the recall and ensure proper calibration protocols are followed.
The recalled product
- Product
- BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 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
- 5
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 (5)
- Serial Numbers: 31001
- 31002
- 31003
- 31004
- 60001
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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