Z-0228-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2014
- Initiation Date
- October 3, 2014
- Termination Date
- December 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 133 devices
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.
Distribution Pattern
US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
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.