FDAMay 5, 2016device
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
What to do
FDA enforcement status: Terminated
Brands named
ellipse a sellipse
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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