MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Class I - DangerousWhat Should You Do?
- Check if you have this product: MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nidek Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Product Codes/Lot Numbers:
MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
Distribution:
Distributed in: US, CA, NE, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0222-2015
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