Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Recall
- Recall Number
- Z-1698-2016
- Event Number
- 74189
- Firm
- Ellipse A/S Agern Alle 11 Horsholm Denmark
- FEI Number
- 3005112495
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- May 5, 2016
- Terminated
- July 29, 2016
Description
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
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 Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions, please call (760) 798-9550.
Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
US - 25