Recall Z-0228-2015— Monteris Medical Corp
Class II · Terminated
Class II FDA medical device recall by Monteris Medical Corp, initiated 2014-10-03, terminated 2014-12-08. It names 3 FDA 510(k) clearances: K141983, K131955, K131278. Product: FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.. Reason: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe..
- Recalling firm
- Monteris Medical Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-03
- Terminated
- 2014-12-08
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K141983 — NEUROBLATE SYSTEM
- K131955 — NEUROBLATE(TM) SYSTEM
- K131278 — MONTERIS MEDICAL NEUROBLATE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
Reason for recall
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Data sourced from openFDA. This site is unofficial and independent of the FDA.