Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Recall
- Recall Number
- Z-1270-2016
- Event Number
- 73468
- Firm
- Laserex Systems Inc.
- FEI Number
- 3002806902
- Product Code
- HQF
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 1, 2016
- Terminated
- October 27, 2016
- Address
- 7138 SHADY OAK RD, EDEN PRAIRIE, MN, 55344-3517
Description
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Ellex Medical Pty Ltd. Planned Action to bring into Compliance: 1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016, 2.All repairs will be made at no cost to the purchaser; and 3.The corrections will be completed by March 30, 2017. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (800) 824-7444.
Worldwide Distribution - US Distribution
72 units plus 2 spare units