da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Su
FDA device recall Z-1180-2008 · posted 2008-06-12 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.
- Action taken
- Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 9 units
- Distribution
- USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA
- Date initiated
- 2007-12-27
- Date posted
- 2008-06-12
- Date terminated
- 2008-08-15
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |