Reported Jun 15, 2016 · Terminated
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Ellipse A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ellipse A/S · Agern Alle 11 · Horsholm, N/A · N/A
Is this the product you have?
- Ellipse NDYAG Laser applicator for Ellipse Multiflex Medical Laser Products
- Lot codes and dates
- All serial numbers
- Amount recalled
- US - 14
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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