Recalls / —
—#119692
Product
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
- 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
- Part number 380990-11: Serial numbers: 324350 325289 325301 325858 325872 325686 325700 325639 325646 324537 324566 324087 324577 324772 324784 324948 325126 325279 325138 325621 325441 325453 325564 323865 323870 323977 324010 324014 324334.
Why it was recalled
Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Root cause (FDA determination)
Software design
Action the firm took
Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3. For questions regarding this recall call 408-523-2244.
Recalling firm
- Firm
- Intuitive Surgical, Inc.
- Address
- 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304
Distribution
- Distribution pattern
- Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
Timeline
- Recall initiated
- 2013-06-08
- Posted by FDA
- 2013-07-11
- Terminated
- 2014-01-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #119692. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.