RobotRisk › Monteris Medical › 03 Oct 2014
FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF:
S3 · 03 Oct 2014 · Monteris Medical
Record
| Company | Monteris Medical |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 03 Oct 2014 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (recall, enforcement, or fleet-wide fault) |
| Scale | FullFire Diffusing Tip Laser Probe, REF: |
| Confidence | high |
| Verified flag | Yes - 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
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 03 Oct 2014 | FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF: | openFDA enforcement | openFDA enforcement |
Monteris Medical other incidents timeline
Medical robotics context
recall context
Monteris Medical industry position
Related incidents
Other Monteris Medical entries
- 04 Jan 2019 - Monteris Medical had a serious recall
- ~Oct 2017 - FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for
- 25 Mar 2016 - FDA Class I recall: NeuroBlate System SideFire Select
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