FDA Device recall Z-1851-2022
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 by Leica Microsystems, citing during internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1851-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-26 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Leica Microsystems |
| Distribution | US |
Product
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Reason
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Identifiers
| code_info | a. 10448976, Serial Numbers: 120322001, 300122001, 170921001, 301221001, 40122001, 140522001, 151221002, 301021002, 81…a. 10448976, Serial Numbers: 120322001, 300122001, 170921001, 301221001, 40122001, 140522001, 151221002, 301021002, 81221002, 100222002, 40222002, 220821001, 300122002, 110322001, 50322001, 180921001, 260821001, 90622001, 120422001, 100522001, 90522001, 210821001, 250122001, 301021001, 100222001; b. 10448950, Serial Numbers: 160222001, 90721001, 50422001, 50422002, 91221001, 160921001, 61221001 |
|---|
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 Proveo 8, Part Number 10449058, 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
All Leica Microsystems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1851-2022%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.