MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
This recall has been terminated (originally issued November 17, 2014).
- Company
- Nidek Inc
- Recall Initiated
- May 24, 2013
- Posted
- November 17, 2014
- Terminated
- November 17, 2014
- Recall Number
- Z-0222-2015
- Quantity
- 5
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Distribution
US Distribution in the states of: CA, NE, and NY.
Lot / Code Info
MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
Root Cause
Software design
Action Taken
Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.
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