Leica M525 F20 Surgical Microscope System Recalled for Tipping Hazard
Leica Microsystems is recalling 160 surgical microscopes because the instrument may tip over when the swing arm is fully extended.
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 3/5 (High).
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 (tipping over) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Leica Microsystems, Inc. is recalling 160 units of the Leica M525 F20 Surgical Microscope System. The recall was initiated after the firm received complaints that the instrument tipped over when the swing arm was fully extended.
The affected products were distributed in the United States and Canada. The recall covers specific serial numbers listed in the official FDA record, including units added in October 2018.
Consumers and healthcare facilities should stop using the affected microscopes and contact Leica Microsystems for instructions on how to resolve the issue.
The recalled product
- Product
- Leica M525 F20 Surgical Microscope System
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- Affected units
- 160
Distribution
Distribution scope not specified by the agency.
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