FDAClass IIDecember 21, 2022

Leica MICROSYSTEMS Provido recall

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

Why was Leica MICROSYSTEMS Provido 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

***EXPANSION 09/08/2023 UPDATE a. Premium Part Number 10448950; Serial Numbers: 160222001, 280622001, 50422001, 50422002, 91221001, 180622001, 170622001, 61221001, 130922001, 120623001, 150623001, 81022001, 200623001, 51022001, 61022001. b. Standard Part Number 10448976; Serial Numbers: 120322001, 300122001, 40222002, 301221001, 40122001, 140522001, 151221002, 81221002, 100222002, 300122002, 110322001, 50322001, 90622001, 120422001, 90522001, 100522001, 250122001, 100222001, 171022001, 80922001, 70623001, 30922001, 91022001.

Product
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Recalling firm
Leica Microsystems, Inc.
Quantity
38 units
Distribution
US Nationwide
Recall date
December 21, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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