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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2132-2014%22
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