FDA Device recall Z-1848-2022
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
- 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, ARveo 8, Part Number 10449063 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-1848-2022 |
| 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, ARveo 8, Part Number 10449063
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 | Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001,…Serial Numbers: 30622001, 41221001, 100522001, 50322001, 60522001, 11221001, 301121001, 20622001, 191121001, 91221001, 61221001, 81221001, 281121001, 291121001, 181121001, 300522001, 71221001, 20322001, 30322001, 60322001, 61221002, 21221001, 241121001, 101221001, 251121001, 31221001, 261121001, 91221002, 101221002, 51221001, |
|---|
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-1848-2022%22
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