Siemens Biograph mCT X-3R Scanners Recalled for Falling Laser Cover Windows
Siemens Medical Solutions is recalling 18 Biograph mCT X-3R 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 hazard involves a component falling off without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 18 units of the Biograph mCT X-3R, Material Number 10248673. These are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used by health care professionals for diagnostic imaging and treatment planning.
The recall was initiated after the manufacturer became aware, through a supplier, that some laser cover windows on the devices may fall off. The affected units were distributed worldwide, including in the United States and various international locations.
Health care facilities should contact Siemens Medical Solutions for instructions on how to address the issue with the laser cover windows.
The recalled product
- Product
- Biograph mCT X-3R, Material Number 10248673 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 anatomic inform
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 18
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 (17)
- Serial Numbers: 11010
- 11013
- 11011
- 11009
- 1006
- 1002
- 1007
- 11012
- 11015
- 11017
- 11016
- 1003
- 1004
- 1005
- 11020
- 11008
- 11019
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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