Device product
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Z-0222-2015
Product summary
- Firm
- Nidek Inc
- Event
- Event 69531
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0222-2015
Official wording
Reason: Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
Code information: MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
Distribution pattern: US Distribution in the states of: CA, NE, and NY.
Derived failure modes
-
Unknown
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.