FDAFDA · Food and drugs·Recall number Z-1697-2016
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Published June 15, 2016 · Recall initiated: May 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ellipse A/S
- Distributor
- Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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