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. .
FDA Recall Z-1270-2016 · Posted None
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Recalling FirmLaserex Systems Inc.
Recall StatusTerminated
Product CodeHQF
Date Initiated2016-02-01
Date Terminated2016-10-27
Product Quantity72 units plus 2 spare units
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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