[Recalled] Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products. — Failure to provide the required instructions specifying a procedure and schedul… | FDA 2016-05-05
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products. |
|---|---|
| Brand / manufacturer | Ellipse A/S |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1698-2016 |
| Country of notice | Denmark |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 May 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
This Class II recall concerns device products distributed in Denmark and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Ellipse A/S
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.