IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. A
FDA device recall Z-1110-2013 · posted 2013-04-13 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
- Action taken
- Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated April 1, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-876-1310 for questions regarding this letter.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1642 customers
- Distribution
- Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
- Date initiated
- 2013-03-15
- Date posted
- 2013-04-13
- Date terminated
- 2014-09-04
- 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 SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |