Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 13 Biograph mCT Flow Edge-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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 13 units of the BIOGRAPH mCT Flow Edge-4R, material number 10528955. 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 11001 through 11013 (specifically 11001, 11002, 11003, 11004, 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, and 11013).
The affected devices were distributed worldwide and nationwide in the United States. The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 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
- 13
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 (14)
- Serial Numbers
- 11001
- 11002
- 11003
- 11004
- 11005
- 11006
- 11007
- 11008
- 11009
- 11011
- 11010
- 11013
- 11012
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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