Siemens Biograph 40 TruePoint PET/CT Scanner Recall for Calibration Error
Siemens is recalling 48 Biograph 40 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, but the source text describes a potential for unexpected values without reporting any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 48 units of the BIOGRAPH 40 TruePoint combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The affected units are identified by Material Number 10097303 and specific serial numbers listed in the agency record. The distribution pattern is worldwide, including US nationwide.
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 source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users of these scanners should verify their equipment against the provided serial numbers and contact Siemens Medical Solutions for further instructions on calibration protocols.
The recalled product
- Product
- BIOGRAPH 40 TruePoint, Material Number 10097303 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
- 48
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: 1003
- 1004
- 1005
- 1006
- 1009
- 1011
- 1012
- 1013
- 1014
- 1015
- 1016
- 1017
- 1018
- 1019
- 1020
- 1022
- 1023
- 1024
- 1028
- 1029
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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