Recall Z-1460-2022— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2022-07-01. It names 2 FDA 510(k) clearances: K150837, K131861. Product: Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401. Reason: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-01
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K150837 — IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K-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
Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Reason for recall
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.