Recall Z-3254-2018 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
| Date | Jul 16, 2018 |
| Status | Terminated |
| Reason | Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use. |
| Root cause | Nonconforming Material/Component |
| Action | On 07/16/2018, the firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" Notification to customers vi a Federal Express and email, and posted on the US Customer Portal . The letter described the product, problem and actions to be taken. The notice states to note that solely having the affected power supply module does not mean the system will encounter a power loss event. To encounter the related power loss scenario above, both of the following two (2) conditions must be met. 1. The system contains the affected power supply. 2. A failure of one of the power supply modules is exp |
| Quantity | 1,014 currently installed on systems |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Ne |
| FDA record | Open on fda.gov |