FDA Device recall Z-0224-2015
Nidek 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 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20 by Nidek, citing when the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0224-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-24 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | CA, IL, IN, MI, MN, NJ, NY, OH, SC, TX, UT |
Product
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
Reason
When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.
Identifiers
| code_info | Model MC-500 Serial numbers: 50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 504…Model MC-500 Serial numbers: 50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382, |
|---|
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-0224-2015%22
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