da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitiv
FDA device recall Z-2734-2015 · posted 2015-09-03 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
- Action taken
- Intuitive sent an Urgent Medical Device Correction letters dated August 21, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Clinical Sales or ISI Customer service at 800-876-1310 Option 3.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 198 affected devices
- Distribution
- Worldwide Distribution - US Nationwide and in the countries of Italy and Norway.
- Date initiated
- 2015-08-17
- Date posted
- 2015-09-03
- Date terminated
- 2016-02-08
- 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 SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |