Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error
Siemens Medical Solutions is recalling four Biograph TruePoint PET/CT scanners due to a risk of unexpected SUV values when using non-Siemens phantoms 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, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a potential calibration error rather than a direct physical injury risk.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling four units of the SYS IVK, Bio mCT-S(40) 3R->4R Upgrade (Material Number 10250743) for the Siemens Biograph TruePoint systems. These 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 affected units are identified by serial numbers 1002, 1001, 11003, and 11004.
The affected units were distributed worldwide and nationwide in the United States. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 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…
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 4
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 (4)
- Serial Numbers: 1002
- 1001
- 11003
- 11004
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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