PlainRecalls
FDA Devices Moderate Class II Ongoing

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Reported: December 21, 2022 Initiated: November 21, 2022 #Z-0477-2023

Product Description

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Reason for Recall

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.

Details

Recalling Firm
Leica Microsystems, Inc.
Units Affected
148 units
Distribution
US Nationwide
Location
deerfield, IL

Frequently Asked Questions

What product was recalled?
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system. Recalled by Leica Microsystems, Inc.. Units affected: 148 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0477-2023.