FDA Device recall Z-0476-2023
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard)
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard) by Leica Microsystems, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0476-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-21 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Leica Microsystems |
| Distribution | US |
Product
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Reason
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.
Identifiers
| code_info | ***EXPANSION 09/08/2023 UPDATE a. Premium Part Number 10448950; Serial Numbers: 160222001, 280622001, 50422001, 50422…***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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0476-2023%22
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