Siemens Biograph 6 TruePoint Scanners Recalled for Calibration Error Risk
Siemens Medical Solutions is recalling 102 Biograph 6 TruePoint scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.
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 a potential for incorrect calibration values without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 102 units of the BIOGRAPH 6 TruePoint combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The affected units are identified by specific serial numbers listed in the recall notice and were distributed worldwide and nationwide in the United States.
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 injuries, illnesses, or deaths associated with this issue.
Healthcare facilities and users of these scanners should verify if their equipment is affected by checking the serial number against the provided list. Users should contact Siemens Medical Solutions for further instructions on how to proceed with the recall and any necessary corrective actions.
The recalled product
- Product
- BIOGRAPH 6 TruePoint, Material Number 10097289 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
- 102
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
- 1009
- 1013
- 1016
- 1028
- 1031
- 1032
- 1033
- 1036
- 1037
- 1038
- 1040
- 1042
- 1052
- 1059
- 1066
- 1070
- 1083
- 1095
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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