Recall Z-0151-2008 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
| Date | Feb 22, 2008 (initiated Oct 4, 2007) |
| Status | Terminated |
| Reason | Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that m |
| Root cause | Mixed-up of materials/components |
| Action | A product recall was initiated on October 4, 2007. Direct and Distributor consignees were sent an Important Product Notice, via electronic mail on October 5, 2007. The firm plans on sending a Field Service Engineer to inspect the system and make any necessary corrections. |
| Quantity | 63 total units |
| Distribution | Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, LA, MA, MD, MN, NC, NJ, NV, OH, PA, PR, SD, TN, TX, WA, and WI, and countries of Belgium, Ireland, Italy, Korea, Russia, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021036 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 Intuitive Surgical, Inc., Jun 26, 2002 |
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |
| K063220 | DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 Intuitive Surgical, Inc., Dec 1, 2006 |
| K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Intuitive Surgical, Inc., Jul 11, 2000 |