Recall Z-1969-2014— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2014-05-21, terminated 2015-05-05. It names 3 FDA 510(k) clearances: K081137, K050369, K021036. Product: Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.. Reason: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-21
- Terminated
- 2015-05-05
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K081137 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
- K050369 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
- K021036 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
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
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Reason for recall
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Data sourced from openFDA. This site is unofficial and independent of the FDA.