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U.S. Department of Health and Human Services

Class 2 Device Recall Ellipse Multiflex system

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 Class 2 Device Recall Ellipse Multiflex systemsee related information
Date Initiated by FirmMay 05, 2016
Create DateJune 09, 2016
Recall Status1 Terminated 3 on July 29, 2016
Recall NumberZ-1697-2016
Recall Event ID 74189
510(K)NumberK140670 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductEllipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Ellipse A/S
Agern Alle 11
Horsholm Denmark
For Additional Information ContactMr 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
ActionEllipse 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 CommerceUS - 14
DistributionNationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = GEX
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