Nidek Excimer Laser Corneal Surgery System recall
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an…
Why was Nidek Excimer Laser Corneal Surgery System recalled?
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
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?
Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
- Product
- Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an…
- Recalling firm
- Nidek Inc
- Quantity
- 14 units
- Distribution
- US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
- Recall date
- November 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)