Siemens Biograph mCT Flow Edge-4R Scanner Recall for Laser Cover Windows
Siemens Medical Solutions is recalling one Biograph mCT Flow Edge-4R scanner because laser cover windows may fall off.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 one unit of the Biograph mCT Flow Edge-4R scanner (Material Number 10528955, Serial Number 11001). The recall was initiated after the manufacturer learned through a supplier that some laser cover windows on the device may fall off.
The affected system is a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner used by health care professionals for diagnostic imaging and treatment planning. The distribution pattern for this specific unit is listed as worldwide, including the United States and various international locations.
No specific instructions for consumers or health care professionals are provided in the source text regarding immediate actions to take. The hazard is limited to the potential detachment of the laser cover windows.
The recalled product
- Product
- Biograph mCT Flow Edge-4R, Material Number 10528955 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…
- 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: 11001
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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Similar recalls
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