daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic in
FDA device recall Z-1245-2007 · posted 2007-09-26 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Product may malfunction and fail to start up on AC power.
- Action taken
- As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05).
- Root cause
- Process control
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 38 units
- Distribution
- Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.
- Date initiated
- 2007-05-14
- Date posted
- 2007-09-26
- Date terminated
- 2007-12-03
- 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 |
|---|---|---|
| DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 (K063220) | Intuitive Surgical, Inc. | 2006-12-01 |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |