Z-0475-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- November 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units
Product Description
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, 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.
Distribution Pattern
US Nationwide
Code Information
Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.