Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0228-2015 — 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. T

U.S. FDA — Device Enforcement · United States · 2014-10-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0228-2015
Date of alert: 2014-10-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Monteris Medical Corp
Product category: device
Product type: Devices

Reported risk: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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