FDA Enforcement
Class II
Terminated
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Recall: Z-1697-2016
·
Reported June 15, 2016
Enforcement
- Recall Number
- Z-1697-2016
- Event ID
- 74189
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ellipse A/S
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 15, 2016
- Initiation Date
- May 5, 2016
- Classification Date
- June 9, 2016
- Termination Date
- July 29, 2016
- Address
- Agern Alle 11, N/A, Horsholm, N/A, N/A, Denmark
Description
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Reason
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Code Info
All serial numbers
Distribution
Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Quantity
US - 14