Medical device recalls Moderate risk

Leica MICROSYSTEMS Provido recalled over fire hazard

Recall date
November 21, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Leica Microsystems, Inc. recalls Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Recall number
Z-0476-2023
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
US Nationwide

Why it was recalled

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

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