Recall Z-1293-2023 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
| Date | Mar 28, 2023 (initiated Feb 10, 2023) |
| Status | Open, Classified |
| Reason | Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications. |
| Root cause | Equipment maintenance |
| Action | On 02/10-13/2023, Intuitive Surgical sent "Urgent Medical Device Correction" letters via email to inform two Groups of Customer (Group 1 and Group 2) that, a population of da Vinci Z and Xi Systems instrument arms (USMs-Universal Surgical Manipulators) have instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel li |
| Quantity | 1,225 total USMs |
| Distribution | U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Austral |
| FDA record | Open on fda.gov |