Recall Z-0670-2007 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
| Date | Mar 29, 2007 (initiated Apr 12, 2006) |
| Status | Terminated |
| Reason | Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique. |
| Root cause | Other |
| Action | The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06. |
| Quantity | 24 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |