FDA Device recall Z-0222-2015
MC-500 Multicolor Laser Photocoagulator using software version 2.20
- FDA Device
- Class II
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class II recall of MC-500 Multicolor Laser Photocoagulator using software version 2.20 by Nidek, citing retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0222-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-24 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | CA, NE, NY |
Product
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Reason
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Identifiers
| code_info | MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class III · 2018-12-26 · Nidek - AUTO REF/KERATOMETER ARK-1s
FDA Device · Class II · 2018-04-18 · Nidek - Final Fit Software Version 1.11 and 1.12
FDA Device · Class II · 2017-03-29 · Nidek - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2015%22
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