Recall Z-1698-2016— Ellipse A/S
Class II · Terminated
Class II FDA medical device recall by Ellipse A/S, initiated 2016-05-05, terminated 2016-07-29. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Ellipse A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-05
- Terminated
- 2016-07-29
- Firm location
- Horsholm, N/A, Denmark
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.