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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:130886

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.

Official recall number

Z-0224-2015

Evidence summary

Product code
HQF
Recall status
Terminated
Event initiated
October 24, 2012
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0224-2015

Field note

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