FDA Device recall Z-1698-2016
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products by Ellipse A S, citing failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1698-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-05 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ellipse A S |
| Distribution | US |
Product
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Reason
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1698-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.