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U.S. Department of Health and Human Services

Class 2 Device Recall Ellipse Nordlys system

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  Class 2 Device Recall Ellipse Nordlys system see related information
Date Initiated by Firm May 05, 2016
Create Date June 09, 2016
Recall Status1 Terminated 3 on July 29, 2016
Recall Number Z-1698-2016
Recall Event ID 74189
Product Classification Powered laser surgical instrument - Product Code GEX
Product Ellipse ND: YAG Laser applicator for Ellipse Nordlys system

Medical Laser Products.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Ellipse A/S
Agern Alle 11
Horsholm Denmark
For Additional Information Contact Mr Jan Enemaerke
760-798-9550
Manufacturer Reason
for Recall		 Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce US - 25
Distribution Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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