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Terminated

Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.

FDA Recall Z-1697-2016 · Posted None

Recalling FirmEllipse A/S
Recall StatusTerminated
Product CodeGEX
Date Initiated2016-05-05
Date Terminated2016-07-29
Product QuantityUS - 14

Reason for Recall

Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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