Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Mod
FDA device recall Z-0670-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
- Action taken
- The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 24 units
- Distribution
- Nationwide.
- Date initiated
- 2006-04-12
- Date posted
- 2007-03-29
- Date terminated
- 2007-12-05
- 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 |