RobotRisk › Monteris Medical › 25 Mar 2016
FDA Class I recall: NeuroBlate System SideFire Select
S4 · 25 Mar 2016 · Monteris Medical
Record
| Company | Monteris Medical |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 25 Mar 2016 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (serious injury, total loss, or grounding) |
| Scale | NeuroBlate System SideFire Select |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class I, recall Z-1614-2016): Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 25 Mar 2016 | FDA Class I recall: NeuroBlate System SideFire Select | 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
- 03 Oct 2014 - FDA Class II recall: FullFire Diffusing Tip Laser Probe, REF:
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