FDA Device recall Z-1270-2016
Ellex Medical Fixed eye Safety filters Model Integre S LP5532
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of Ellex Medical Fixed eye Safety filters Model Integre S LP5532 by Laserex Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1270-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-01 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Laserex Systems |
| Distribution | n/a |
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. .
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.
Identifiers
| code_info | Model Number : 3143270 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1270-2016%22
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