Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1127-2015 — MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.

U.S. FDA — Device Enforcement · United States · 2012-03-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1127-2015
Date of alert
2012-03-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nidek Inc
Product category
device
Product type
Devices
Reported risk: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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