The Recall Desk
HighFDA (Devices)·Z-3175-2018·Announced 2018-09-26

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.

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 (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.
Category
Medical Device — Surgical Microscope
Hazard
Affected units
160

Distribution

Distribution scope not specified by the agency.

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