Device product
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Z-1698-2016
Product summary
- Firm
- Ellipse A/S
- Event
- Event 74189
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 25
- Official record key
device-enforcement:Z-1698-2016
Official wording
Reason: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Code information: All serial numbers
Distribution pattern: Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Derived failure modes
-
Unknown
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.