Recall Z-1245-2007 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
| Date | Sep 26, 2007 (initiated May 14, 2007) |
| Status | Terminated |
| Reason | Product may malfunction and fail to start up on AC power. |
| Root cause | Process control |
| Action | As of 9/12/2007, the firm has conducted a field inspection of any involved units via service visit. No other notice is planned or indicated by the firm's submission. The firm feels that the risk associated with this issue is minimal, and therefore, any advanced notification is unneccessary. If any system failed one or more of the inspection points, its APB (3510404-04) was replaced with a verified APB (351040-04 or 351040-05). |
| Quantity | 38 units |
| Distribution | Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore. |
| FDA record | Open on fda.gov |