Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2053-2012·Announced 2012-08-01

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.

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. 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…
Manufacturer: Leica Microsystems, Inc.
Category: Medical Device — Surgical Microscope
Hazard: malfunction
illumination-reduction

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

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Same manufacturer · Leica Microsystems, Inc.

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