MC-500 Multicolor Laser Photocoagulator using software recall
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus…
Why was MC-500 Multicolor Laser Photocoagulator using software recalled?
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
- Product
- MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus…
- Recalling firm
- Nidek Inc
- Quantity
- 5
- Distribution
- US Distribution in the states of: CA, NE, and NY.
- Recall date
- November 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)