Ellipse A/S recalls Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
- Recall date
- May 5, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1698-2016
- 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 Nordlys system Medical Laser Products.
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