Recalls / —
—#116999
Product
IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
- FDA product code
- NAY — System, Surgical, Computer Controlled Instrument
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K081137
- Affected lot / code info
- Model number 550650-05 (P8)
Why it was recalled
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated April 1, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-876-1310 for questions regarding this letter.
Recalling firm
- Firm
- Intuitive Surgical, Inc.
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304
Distribution
- Distribution pattern
- Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Timeline
- Recall initiated
- 2013-03-15
- Posted by FDA
- 2013-04-13
- Terminated
- 2014-09-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #116999. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.