Device product
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Z-1381-2023
Product summary
- Event
- Event 91909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 boxes( 5 probes/box)
- Official record key
device-enforcement:Z-1381-2023
Official wording
Reason: Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
Code information: UDI-DI: 15051684029643 Lot Number: 5762110
Distribution pattern: US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Derived failure modes
-
Unknown
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure