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RobotRiskMonteris Medical › 03 Oct 2014

FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF:

S3 · 03 Oct 2014 · Monteris Medical

Record

CompanyMonteris Medical
IndustryMedical robotics
Type(s)recall
Date03 Oct 2014 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
ScaleFullFire Diffusing Tip Laser Probe, REF:
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-0228-2015): Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)
DateSupporting source rowPublisherLink
03 Oct 2014 FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: openFDA enforcement openFDA enforcement

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