ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical End
FDA device recall Z-2731-2014 · posted 2014-09-30 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
- Action taken
- Intuitive sent an Urgent Medical Device Correction letter dated September 11, 2014 to all consignees via trackable mail system. Letters identified the issue and provides information for users should a error code be displayed. For questions contact your Clinical Sales Representative or Intuitive Surgical Customer Service
- Root cause
- Other
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 75 devices
- Distribution
- Worldwide Distribution - US nationwide and the countries of: Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom.
- Date initiated
- 2014-09-11
- Date posted
- 2014-09-30
- Date terminated
- 2014-10-23
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |