FDA Device recall Z-1127-2015
MC-500 Multicolor Laser Photocoagulator
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of MC-500 Multicolor Laser Photocoagulator by Nidek, citing the spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1127-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-27 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | US |
Product
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Reason
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Identifiers
| code_info | Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2015%22
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