Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1698-2016 — Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.

U.S. FDA — Device Enforcement · Denmark · 2016-05-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1698-2016
Date of alert
2016-05-05
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
Ellipse A/S
Product category
device
Product type
Devices
Reported risk: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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