Siemens Biograph 64 PET/CT Scanner Recall for Calibration Error
Siemens is recalling 15 Biograph 64 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 hazard involves potential data inaccuracy (unexpected SUV 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 15 units of the BIOGRAPH 64 - 3 Ring PET/CT scanners (Material Number 08727450). The affected units were distributed worldwide and across the United States. The recall involves specific serial numbers: 1001, 1002, 1003, 1004, 1007, 1010, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, and 1022.
The recall was initiated because Siemens Medical Solutions, Molecular Imaging identified a potential for unexpected Standardized Uptake Value (SUV) readings if a non-Siemens phantom is used for the scanner's calibration. This issue may affect the accuracy of the imaging data produced by the device.
Healthcare facilities and users of these scanners should contact Siemens Medical Solutions USA Inc. for further instructions on how to address this calibration issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- BIOGRAPH 64 - 3 Ring, Material Number 08727450 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
- 15
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 (15)
- Serial Numbers: 1001
- 1002
- 1003
- 1004
- 1007
- 1010
- 1012
- 1013
- 1014
- 1015
- 1016
- 1017
- 1018
- 1019
- 1022
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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