Ellipse ND: YAG Laser applicator for Ellipse Nordlys recall
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Why was Ellipse ND: YAG Laser applicator for Ellipse Nordlys recalled?
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
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?
All serial numbers
- Product
- Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
- Recalling firm
- Ellipse A/S
- Quantity
- US - 25
- Distribution
- Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)