FDA Device recall Z-2132-2014
MC-500 Multicolor Laser Photocoagulator
- FDA Device
- Class II
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class II recall of MC-500 Multicolor Laser Photocoagulator by Nidek, citing laser aperture label was not affixed to device prior to shipment in the US.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2132-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-09 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | US |
Product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Reason
Laser aperture label was not affixed to device prior to shipment in the US.
Identifiers
| code_info | Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 5…Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Nidek
- NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium e…
FDA Device · Class III · 2020-01-08 · Nidek - RT-5100 Refractor, a component of the Epic-5100 System
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-2132-2014%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.