Recall Z-1698-2016 ยท GEX Powered Laser Surgical Instrument
Ellipse A/S
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
| Date | May 5, 2016 |
| Status | Terminated |
| Reason | Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Ellipse A/S has evaluated our instructions in the Service Manual and brought those parts into the Operator's Manual as well which we believe is relevant and usable for the end-user of the product. The details in efficiently implementing the distribution of the manual has been evaluated and coordinated with our service provider in the US. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Dr |
| Quantity | US - 25 |
| Distribution | Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.