Recall Z-1381-2023— Angiodynamics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2023-03-02. It names one FDA 510(k) clearance: K183385. Product: NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110. 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.
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-02
- Firm location
- Queensbury, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.