Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products recall — FDA Z-1697-2016
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Overview of recall records associated with Ellipse A/S, including dates, categories and classifications where available.
Classification mix: Class II: 2.
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
This page summarizes recall records in which the official source identifies Ellipse A/S as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.