Device product
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. .
Z-1270-2016
Product summary
- Event
- Event 73468
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units plus 2 spare units
- Official record key
device-enforcement:Z-1270-2016
Official wording
Reason: 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.
Code information: Model Number : 3143270
Distribution pattern: Worldwide Distribution - US Distribution
Derived failure modes
-
Device software or design
design error