Derived label

Device software or design

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.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: design error
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Laserex Systems Inc.