da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical,
FDA device recall Z-1161-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.
- Action taken
- Recall initiated the recall on July 1, 2009. US consignee recall was initiated on July 7, 2009. All affected consignees have been notified via e-mail communication followed by a field service engineer visit. Customers with questions or with need for additional assistance regarding the notification, please contact the firm's Intuitive Surgical Customer Service Department at 1-800-876-1310 toll free.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 782 units
- Distribution
- Product was distributed to 551 consignees throughout the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, P
- Date initiated
- 2009-07-15
- Date posted
- 2010-04-05
- Date terminated
- 2011-02-11
- 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 |