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Ellipse A/S recalls Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Recalled June 15, 2016 · FDA recall Z-1698-2016 · Ellipse A/S
Hazard
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system. · FDA Class II
Units
US - 25
Sold at
Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Description
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Product
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Manufacturer(s)
Ellipse A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →