Siemens Biograph mCT-X 3R PET/CT Scanner Recall for Calibration Error
Siemens is recalling 22 Biograph mCT-X 3R 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 source text explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 22 units of the Biograph mCT-X 3R, a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. 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 are distributed worldwide and across the United States. The specific serial numbers involved are 1002, 1003, 1004, 1005, 1006, 1007, 11009, 11010, 11011, 11012, 11008, 11013, 11015, 11019, 11017, 11018, 11020, 31021, 31022, 31023, 11014, and 1001.
Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address this issue. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Biograph mCT-X 3R, MATERIAL NUMBER 10248673 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
- 22
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: 1002
- 1003
- 1004
- 1005
- 1006
- 1007
- 11009
- 11010
- 11011
- 11012
- 11008
- 11013
- 11015
- 11019
- 11017
- 11018
- 11020
- 31021
- 31022
- 31023
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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