FDA Medical Device Recalls (openFDA)
Ellipse A/S: Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
- Recall number
- Z-1697-2016
- Recalling firm
- Ellipse A/S
- Product
- Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
- Status
- Terminated
- Initiated
- 2016-05-05
- Posted
- not on file
- Terminated
- 2016-07-29
- 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 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
- US - 14
- Distribution
- Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K140670"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3005112495
- Firm city
- Horsholm
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28