Leica M525 F50 Surgical Microscope Recalled for Illumination Malfunction
Leica Microsystems is recalling M525 F50 surgical microscopes because a malfunction can cause reduced illumination when used with specific remote control adapters.
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. The hazard involves a malfunction causing reduced illumination, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Leica Microsystems, Inc. is recalling the Leica M525 F50 Surgical Microscope (Article No. 10338422). The recall involves 39 units distributed in the United States and 4 units in Canada. The devices were distributed nationwide in the US, including in California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah, West Virginia, and Puerto Rico.
The recall was initiated after Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can occur. This issue is observed when the Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or a motorized dual video adapter. The intended use of the device is for improving visibility of objects through magnification and illumination for observation, documentation, and medical treatment.
Healthcare facilities and users should stop using the affected devices and contact Leica Microsystems for instructions on how to proceed. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can
- Manufacturer
- Leica Microsystems, Inc.
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 serial numbers 110311001
- 120312001
- 20412001
- 260112001
- 300911001
- 40811001
- 80411001
- 90312001
- 10311002
- 90611001
- 260711001
- 20911001
- 200911001
- 210911001
- 111011001
- 141011001
- 241011001
- 121211001
- 141211001
- 151211001
Distribution
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