FDA Medical Device Recalls (openFDA)
Laserex Systems Inc.: 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 number
- Z-1270-2016
- Recalling firm
- Laserex Systems Inc.
- 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. .
- Status
- Terminated
- Initiated
- 2016-02-01
- Posted
- not on file
- Terminated
- 2016-10-27
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 72 units plus 2 spare units
- Distribution
- Worldwide Distribution - US Distribution
- Lot, serial or model codes
- Model Number : 3143270
- 510(k) numbers
- ["K052777"]
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 3002806902
- Firm city
- EDEN PRAIRIE
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28