Leica Surgical Microscopes Recalled for Potential Overheating and Smoke
Leica Microsystems is recalling 381 M525 and M720 surgical microscopes because an electronic component may overheat, causing smoke and smell.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential fire/smoke) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Leica Microsystems, Inc. is recalling 381 units of Leica M525 OH4 and Leica M720 OH5 surgical microscopes. The recall involves specific serial numbers listed in the official FDA notice. These devices are intended for improving the visibility of objects through magnification and illumination during surgical procedures.
The recall was initiated because an electronic component within the microscopes could potentially overheat. This overheating may result in smoke and a smell emanating from the ventilation openings of the illumination units. These openings are located opposite and away from the surgeon and patient side of the device.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries. Users of these devices should stop using them and contact Leica Microsystems for instructions on repair or replacement.
The recalled product
- Product
- Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 381
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)
- OH5-51313
- OH4-112214
- OH5-49112
- OH5-67914
- OH4-101213
- OH5-20238
- OH4-91913
- OH5-43312
- OH5-54113
- OH5-64514
- OH4-103014
- OH4-106514
- OH4-87112
- OH4-95413
- OH4-94213
- OH4-106014
- OH4-105514
- OH4-94813
- OH4-102514
- OH4-91113
Distribution
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