Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 25 Biograph mCT Flow 64-4R 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. The hazard involves potential diagnostic inaccuracy (unexpected SUV values) due to calibration with non-Siemens phantoms, which is a significant quality issue but does not involve reported injuries, deaths, or immediate physical harm to patients.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 25 units of the BIOGRAPH mCT Flow 64-4R (Material Number 10529161) medical devices. 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 the company became aware of a potential for unexpected Standardized Uptake Value (SUV) values if a non-Siemens phantom is used for calibration. The affected units were distributed worldwide and across the United States.
Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA Inc. for further instructions on how to address the calibration issue. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 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.
- Affected units
- 25
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: 11002
- 11003
- 11004
- 11001
- 11005
- 11006
- 11008
- 11009
- 11007
- 11010
- 11011
- 11012
- 11014
- 11015
- 11013
- 11017
- 11016
- 11021
- 11018
- 11019
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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