Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 49 Biograph 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 incorrect 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 49 units of the BIOGRAPH 64-4R TruePoint w/TrueV PET/CT scanners (Material Number 10097302). The recall covers specific serial numbers listed in the agency record and affects units distributed worldwide and across the United States.
The recall was initiated because Siemens Medical Solutions, Molecular Imaging identified 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 injuries, illnesses, or deaths associated with this issue.
Healthcare facilities and users of these devices should verify their calibration procedures and contact Siemens Medical Solutions for further instructions on how to address the potential calibration error.
The recalled product
- Product
- BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 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 inform
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 49
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
- 1003
- 1004
- 1005
- 1006
- 1007
- 1008
- 1011
- 1013
- 1014
- 1015
- 1016
- 1017
- 1019
- 1020
- 1021
- 1022
- 1023
- 1024
- 1025
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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