Siemens Biograph mCT S(20) - 3R PET/CT Scanner Recall
Siemens is recalling 143 Biograph mCT S(20) - 3R scanners due to a potential for unexpected SUV values if a non-Siemens phantom is 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, and the hazard is a potential for unexpected calibration values 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 143 units of the BIOGRAPH mCT S(20) - 3R, material number 10507786. These 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.
The recall is due to 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 nationwide in the US.
Healthcare facilities should contact Siemens Medical Solutions for instructions on how to proceed with the recall and ensure proper calibration protocols are followed.
The recalled product
- Product
- BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 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
- 143
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: 11001
- 11002
- 11005
- 11006
- 11007
- 11009
- 11012
- 11013
- 11014
- 11015
- 11003
- 11017
- 11019
- 11020
- 11010
- 11022
- 11008
- 11004
- 11024
- 11040
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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