Recall Z-1381-2023 ยท OAB Low Energy Direct Current Thermal Ablation System
Angiodynamics, Inc.
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
| Date | Apr 12, 2023 (initiated Mar 2, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | AngioDynamics issued Urgent Medical Device Recall Letter on March 2, 2023 via Federal Express. Letter states reason for recall health risk and action to take: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location. Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. ComplFx Reply Verification Tracking Form: Attn: NK Probe 5-Pa |
| Quantity | 10 boxes( 5 probes/box) |
| Distribution | US Nationwide Distribution: CA,CO, FL, IA, NY, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183385 | NanoKnife System Angiodynamics, Jun 18, 2019 |