Siemens Biograph mCT-X Scanner Recall Due to Falling Laser Cover Windows
Siemens Medical Solutions is recalling Biograph mCT-X scanners because laser cover windows may fall off.
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 injuries or illnesses, fitting the criteria for a moderate severity recall involving a potential hazard without confirmed harm.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling one unit of the Biograph mCT-X w/TrueV Upgrade, Material Number 10250745. The product is a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner intended for use by trained health care professionals to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function.
The recall was initiated after Siemens Medical Solutions, Molecular Imaging became aware through a supplier that some laser cover windows on the device may fall off. The agency classified this recall as Class II. The affected unit has Serial Number 1001 and was distributed worldwide, including in the United States and various international locations.
Health care facilities using this specific scanner should contact Siemens Medical Solutions for instructions on how to address the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and an
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 1
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 (1)
- Serial Numbers: 1001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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