da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewe
FDA device recall Z-0088-2014 · posted 2013-10-28 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
- Action taken
- Advisory letters were sent to all affected customers on 10/17/11 informing them to contact Customer Service prior to moving the system outside of the hospital.
- Root cause
- Use error
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1,090 consoles
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia
- Date initiated
- 2011-10-17
- Date posted
- 2013-10-28
- Date terminated
- 2013-10-28
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |