Intuitive Surgical da Vinci Si Surgical System (IS3000); Mfg by: Intuitive Surgical, Sunnyvale, CA 94086 Product Usage:
FDA device recall Z-2930-2011 · posted 2011-08-03 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.
- Action taken
- Intuitive Surgical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 1, 2011 to all affected customers. Customers were asked to complete the attached response form and return as per the instructions. The letter identifies the product, problem, and actions to be taken by the customers. The letter reinforce to customers to follow the product labeling WARNING. The letter states that all affected customers sites will be receiving a call from a Customer Support staff to schedule a retrofit of the component. A letter was also sent to non affected customers to inform them of the urgent medical device correction and actions to be taken. If you have any questions, please contact Customer Service at 1-800-876-1310 or for Outside United States call +41 21 821 2020.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 183
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of: Belgium, Czech Republic, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Netherlands, Norway, Philippines, Portugal, S
- Date initiated
- 2011-07-05
- Date posted
- 2011-08-03
- Date terminated
- 2011-09-02
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 (K090993) | Intuitive Surgical, Inc. | 2009-12-16 |