Leica Microsystems, Inc. Recall 90818
Description: Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Leica Microsystems, Inc. Recall 90818 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1848-2022 |
| Event ID | 90818 |
| Event Description | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 30 devices |
| Recall 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. |
| Device Classification | 20221005 |
| Device Code Info | 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, |
| Center Classification Date | 20220929 |
| Recall Initiation Date | 20220826 |
| Recalling Firm | Leica Microsystems, Inc. |
| Initial Notification | Letter |
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