Ellipse A/S recalls Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.

Recall date

May 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1697-2016

FDA classification

Class II

Brand / firm

Ellipse A/S

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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