Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive S
FDA device recall Z-1244-2007 · posted 2007-09-26 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the previous User Manual.
- Action taken
- As of 9/7/2007, Intuitive Field Service Engineers have performed the upgrade via service visit on 292 of 293 U.S. systems listed on the affected sites list. A notification letter that the upgrade has been performed was left with each site after the upgrade has been completed. The firm's distributors received advance notice of the upgrades 9/13/2007.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 405
- Distribution
- Worldwide, including USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Romania, Saudi Arabia
- Date initiated
- 2007-05-03
- Date posted
- 2007-09-26
- Date terminated
- 2008-07-02
- 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 IS1000 (K021036) | Intuitive Surgical, Inc. | 2002-06-26 |
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM (K990144) | Intuitive Surgical, Inc. | 2000-07-11 |