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.
FDA Recall Z-0228-2015 · Posted 2014-11-19
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Recalling FirmMonteris Medical Corp
Recall StatusTerminated
Product CodeGEX
Date Initiated2014-10-03
Date Terminated2014-12-08
Product Quantity133 devices
Reason for Recall
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Firm Action
Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Action to be taken by user:
Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment.
Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.
Root Cause
Process control
Distribution Pattern
US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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