Siemens Biograph mCT PET/CT Scanners Recalled for Falling Laser Cover Windows
Siemens Medical Solutions is recalling 102 Biograph mCT PET/CT 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 score.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 102 units of the Biograph mCT S(64)-4R, a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. 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 nationwide in the United States and internationally to numerous countries. The specific serial numbers for the affected units are listed in the recall documentation.
Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this issue.
The recalled product
- Product
- Biograph mCT S(64)-4R, Material Number 10248672 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 in
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 102
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: 1004
- 11046
- 11064
- 11036
- 11030
- 11093
- 11033
- 11032
- 11041
- 11042
- 11043
- 11044
- 11047
- 11053
- 11069
- 11071
- 11078
- 11079
- 11084
- 11082
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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