FDA-Device2023-04-19Class II

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Hazard

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

Sold states
US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Affected count
10 boxes( 5 probes/box)
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2023

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