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Z-1698-2016 Class II Terminated

Recalled by Ellipse A/S — Horsholm, N/A

FDA device recall Z-1698-2016 was initiated by Ellipse A/S on May 5, 2016 and is designated Class II. Reason for recall: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system. The recall status is terminated (terminated July 29, 2016). Affected quantity: US - 25.

Recall Details

Product Type: Devices
Report Date: June 15, 2016
Initiation Date: May 5, 2016
Termination Date: July 29, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US - 25

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.

Distribution Pattern

Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.

Code Information

All serial numbers