Ellipse A/S: Medical Device Recall in 2016 - (Recall #: Z-1697-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 5, 2016

Date Posted: June 15, 2016

Recall Number: Z-1697-2016

Event ID: 74189

Reason for Recall:

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

Status: Terminated

Product Quantity: US - 14

Code Information:

All serial numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated