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U.S. Department of Health and Human Services

Class 2 Device Recall FullFire Diffusing Tip Laser Probe

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 Class 2 Device Recall FullFire Diffusing Tip Laser Probesee related information
Date Initiated by FirmOctober 03, 2014
Date PostedNovember 19, 2014
Recall Status1 Terminated 3 on December 08, 2014
Recall NumberZ-0228-2015
Recall Event ID 69514
510(K)NumberK131278 K131955 K141983 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductFullFire 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.
Code Information serial numbers: 20414-1-C1274-03, 20414-1-C1274-04, 20414-1-C1274-06, 20414-1-C1274-07, 20414-1-C1274-08, 20414-1-C1274-09, 20414-1-C1274-11, 20414-1-C1274-12, 20414-1-C1274-13, 20414-1-C1274-17, 20414-1-C1274-19, 20414-1-C1274-20, 20414-1-C1367-01, 20414-1-C1367-02, 20414-1-C1367-04, 20414-1-C1367-05, 20414-1-C1367-06, 20414-1-C1367-07, 20414-1-C3302-02, 20414-1-C3302-05, 20414-1-C3302-08, 20414-1-C3302-10, 20414-1-C3302-12, 20414-1-C3302-13, 20414-1-C3302-14, 20414-1-C3302-15, 20414-1-C3302-16, 20414-1-C3302-17, 20414-1-C3502-01, 20414-1-C3502-02, 20414-1-C3502-03, 20414-1-C3502-05, 20414-1-C3502-06, 20414-1-C3502-07, 20414-1-C3502-08, 20414-1-C3502-09, 20414-1-C3502-10, 20414-1-C3502-11, 20414-1-C3502-12, 20414-1-C3502-13, 20414-1-C3502-14, 20414-1-C3502-15, 20414-1-C3502-16, 20414-1-C3502-17, 20414-2-C1275-01, 20414-2-C1275-02, 20414-2-C1275-03, 20414-2-C1275-04, 20414-2-C1275-05, 20414-2-C1275-06, 20414-2-C1275-07, 20414-2-C1275-08, 20414-2-C1275-09, 20414-2-C1275-11, 20414-2-C1275-12, 20414-2-C1275-13, 20414-2-C1275-15, 20414-2-C1275-16, 20414-2-C1275-17, 20414-2-C1275-18, 20414-2-C1275-19, 20414-2-C1275-20, 20414-2-C1404-01, 20414-2-C1404-02, 20414-2-C1404-03, 20414-2-C1404-04, 20414-2-C1404-06, 20414-2-C1404-07, 20414-2-C1404-08, 20414-2-C1431-08, 20414-3-C1277-01, 20414-3-C1277-02, 20414-3-C1277-03, 20414-3-C1277-04, 20414-3-C1277-05, 20414-3-C1277-06, 20414-3-C1277-07, 20414-3-C1277-08, 20414-3-C1277-09, 20414-3-C1277-10, 20414-3-C3154-01, 20414-3-C3154-02, 20414-3-C3154-03, 20414-3-C3154-04, 20414-3-C3154-05, 20414-3-C3154-06, 20414-3-C3154-08, 20414-3-C3154-09, 20414-3-C3154-10, 20414-3-C3154-11, 20414-3-C3154-12, 20414-3-C3154-13, 20414-3-C3154-14, 20414-3-C3154-15, 20414-3-C3154-16, 20414-3-C3154-17, 20414-3-C3154-18, 20414-3-C3154-19, 20414-3-C3309-01, 20414-3-C3309-03, 20414-3-C3309-05, 20414-3-C3442-01, 20414-3-C3442-02, 20414-4-C1278-01, 20414-4-C1278-02, 20414-4-C1278-03, 20414-4-C1278-04, 20414-4-C1278-05, 20414-4-C1278-06, 20414-4-C1278-07, 20414-4-C1278-08, 20414-4-C1278-09, 20414-4-C1278-10, 20414-4-C1278-11, 20414-4-C1278-12, 20414-4-C1278-13, 20414-4-C3315-01, 20414-4-C3315-04, 20414-4-C3315-05, 20414-4-C3315-06, 20414-4-C3315-07, 20414-4-C3315-08, 20414-4-C3315-09, 20414-4-C3433-01, 20414-4-C3433-02, 20414-4-C3433-03, 20414-4-C3433-04, 20414-4-C3433-05, 20414-5-C1279-10, 20414-5-C1279-14, 20414-5-C1279-15, 20414-5-C3322-01, 20414-5-C3322-02.
Recalling Firm/
Manufacturer		 Monteris Medical Corp
16305 36th Ave N Suite 200
Plymouth MN 55446-2884
For Additional Information ContactJohn Schellhorn
763-253-4712
Manufacturer Reason
for Recall		Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
FDA Determined
Cause 2		Process control
ActionMonteris 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.
Quantity in Commerce133 devices
DistributionUS Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
510(K)s with Product Code = GEX
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