da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in t
FDA device recall Z-2630-2017 · posted 2017-06-06 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
- Action taken
- Intuitive Surgical sent an Field Safety Notice letter dated June 1, 2017 to customers. The letter was sent electronically via through our da Vinci customer portal via email to the affected sites on June 1, 2017. Letters are sent to the da Vinci Coordinator, Recall Coordinator and/or Risk Management. The customer will receive a hard copy of this letter on June 6, 2017 via Fed Ex. The letter identified the affected product, problem and actions to be taken. For questions contact your Clinical Sales Representative.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan
- Date initiated
- 2017-06-01
- Date posted
- 2017-06-06
- Date terminated
- 2017-10-02
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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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 |