FDA-Device2022-12-21Class II
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Leica Microsystems, Inc.
Hazard
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.
Sold states
US Nationwide
Affected count
38 units
Manufactured in
10 Parkway North blvd ste 300, N/A, deerfield, IL, United States
Products
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2023Don't want to check this manually?
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