FDA Device recall Z-0475-2023
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system 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-0475-2023 |
| 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 Proveo 8, Part Number 10449058, 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 | Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001,…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Leica Microsystems
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems - Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard)
FDA Device · Class II · 2022-12-21 · Leica Microsystems - Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Device · Class II · 2022-10-05 · Leica Microsystems - Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Device · Class II · 2022-10-05 · Leica Microsystems - Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA Device · Class II · 2022-10-05 · Leica Microsystems
All Leica Microsystems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0475-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.