Recall Z-1262-2023 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
| Date | Mar 16, 2023 (initiated Jan 24, 2023) |
| Status | Open, Classified |
| Reason | Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury. |
| Root cause | Component change control |
| Action | On 01/24/2023, New Field Safety Notices were sent to customers. In addition, some customers received another notice informing them that additional preventative maintenance data would need to be collected by the recalling firm's field service personnel, to determine if additional devices were affected. On 1/27/2023, updated New Field Safety Notices were sent to two additional customers. Customers were asked to do the following: 1) Review this Field Safety Notification with all system users and place a copy of it with Instructions for use (IFU) of the system. 2) Complete and return the Acknowl |
| Quantity | 9 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France |
| FDA record | Open on fda.gov |