Reported Apr 13, 2016 · Terminated
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the…
Laserex Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Laserex Systems Inc. · 7138 SHADY OAK RD · EDEN PRAIRIE, MN · 55344-3517
Is this the product you have?
- 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. .
- Lot codes and dates
- Model Number3143270
- Amount recalled
- 72 units plus 2 spare units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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