Intuitive Surgical, Inc. Recall 91505
Description: 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
Intuitive Surgical, Inc. Recall 91505 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1262-2023 |
| Event ID | 91505 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France |
| Quantity | 9 |
| Recall 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. |
| Device Classification | 20230322 |
| Device Code Info | System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962 |
| Center Classification Date | 20230316 |
| Recall Initiation Date | 20230124 |
| Recalling Firm | Intuitive Surgical, Inc. |
| Initial Notification | Letter |
| Similar To |