da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 9408
FDA device recall Z-1202-2012 · posted 2012-03-13 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
- Action taken
- Intuitive Surgical sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 3, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provided new instructions for use. Additionally, a Device Correction Response Form was enclosed for customers to complete and return via fax to 408-523-1390. Contact Intuitive Surgical Customer Service at 1-800-876-1310 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1966 systems are in commerce at hospital locations.
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-02-06
- Date posted
- 2012-03-13
- Date terminated
- 2012-05-09
- 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 |
| DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 (K063220) | Intuitive Surgical, Inc. | 2006-12-01 |