Z-1697-2016Class II

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

Name: Z-1697-2016 Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products
Creator: Ellipse A/S
Published: 2016-05-05
License: https://open.fda.gov/license/

Ellipse A/S / initiated 2016-05-05 / Terminated / root cause: manufacturing process

FDA source

Ellipse A/S began a recall of Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products on 2016-05-05. FDA classified it as Class II and gives the reason as "Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1697-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-05
Posted: 2016-06-09
Terminated: 2016-07-29
Recalling firm: Ellipse A/S
Product: Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Root cause tag: manufacturing process
FDA 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 in commerce: US - 14
Distribution: Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1697-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09
Z-1698-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09

Product code GEX

K140670Class IIEllipse I2pl+/ellipse Multiflex+Ellipse A/S / cleared 2014-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)