EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel S
FDA device recall Z-0063-2015 · posted 2014-10-10 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
- Action taken
- Urgent medical device correction letter was sent to all consignees on 9/22/14 by trackable mail system. Letters identified the issue and provides information for users should a error code be displayed.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1,483 devices
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands,
- Date initiated
- 2014-09-17
- Date posted
- 2014-10-10
- Date terminated
- 2015-06-01
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOWRIST ONE VESSEL SEALER (K130266) | Intuitive Surgical, Inc. | 2013-08-29 |