Recall Z-0228-2015 ยท GEX Powered Laser Surgical Instrument
Monteris Medical Corp
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 energ
| Date | Nov 19, 2014 (initiated Oct 3, 2014) |
| Status | Terminated |
| Reason | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. |
| Root cause | Process control |
| 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 asses |
| Quantity | 133 devices |
| Distribution | US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA |
| FDA record | Open on fda.gov |