Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical… — Class II medical device recall Z-1698-2016
Terminated recall by Ellipse A/S, reported 2016-06-15, distributed nationwide. Failure to provide the required instructions specifying a procedure and schedule for calibration of the measur
| Recall number | Z-1698-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ellipse A/S, Horsholm, N/A, Denmark |
| Recall initiated | 2016-05-05 |
| Classified | 2016-06-09 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 25 |
Product
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Reason for recall
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1698-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.