Siemens Biograph mCT-X 4R PET/CT Scanners Recalled for Calibration Error
Siemens is recalling 83 Biograph mCT-X 4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a High severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 83 units of the Biograph mCT-X 4R, 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) readings if a non-Siemens phantom is used for the device's calibration.
The affected units are distributed worldwide and across the United States. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the calibration issue. The source text does not specify a corrective action or a deadline for compliance.
The recalled product
- Product
- Biograph mCT-X 4R, MATERIAL NUMBER 10248670 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
- 83
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
- 1001
- 1004
- 1005
- 1006
- 1008
- 1009
- 1010
- 1007
- 1011
- 11013
- 11014
- 11015
- 11016
- 11017
- 11018
- 11020
- 11012
- 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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