Siemens Biograph mCT Flow 40-4R Recalled for Calibration Error Risk
Siemens Medical Solutions is recalling nine Biograph mCT Flow 40-4R scanners due to a potential for unexpected SUV values if non-Siemens phantoms are used for calibration.
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 a potential for incorrect calibration values (unexpected SUV) rather than a direct physical injury or reported illness, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling nine units of the BIOGRAPH mCT Flow 40-4R (Material Number 10529159). 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 manufacturer 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 11001 through 11009.
The affected units were distributed worldwide and nationwide in the United States. Healthcare facilities using these devices should contact Siemens Medical Solutions for further instructions on how to address the calibration issue.
The recalled product
- Product
- BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 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
- 9
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 (9)
- Serial Numbers: 11004
- 11001
- 11002
- 11003
- 11005
- 11006
- 11007
- 11008
- 11009
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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