RobotRisk / Monteris Medical / 2014-10-03

medical robotics · recall

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

S3 · 10/03
2014 · Monteris Medical

Record

Company	Monteris Medical
Category	medical robotics
Type	recall
Date	10/03 2014
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	S3 (recall, enforcement, or fleet-wide fault)
Scale	FullFire Diffusing Tip Laser Probe, REF:
Confidence	high
Verification	Yes - adversarially checked against the cited source
Source	openFDA enforcement

What happened

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.

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