da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- September 20, 2022
- Posted
- October 25, 2022
- Recall Number
- Z-0133-2023
- Quantity
- 162
- Firm Location
- Sunnyvale, CA
Reason for Recall
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
Distribution
US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC
Lot / Code Info
Software version P10 (OS4 v10.0.0/A70_P10_B738) SOFTWARE,EMBEDDED RLS,IS4000 AND IS4200,A70_P10_B738 (Model: 610092-738) on Model Name/Model Number/UDI-DI: ASSY,PSCART,IS4000,4-ARM,P10/380652-55/00886874110720, ASSY,SSC,IS4000,P10/380677-28/00886874110744, ASSY,VSS VISION SYSTEM,IS4000,P10/381121-45/00886874110898, ASSY,PSCART,IS4200,P10/380620-47/00886874115404, ASSY,VSC,IS4000,RECONDITIONED,P10/380721-15/00886874115343, ASSY,SSC,IS4000,RECONDITIONED,P10/380723-16/00886874115374
Root Cause
Software Design Change
Action Taken
On 09/20/22, correction notices were mailed to customers. Customers were advised of the following: 1) The system software version can be located on the Vision Cart Touchscreen in the Troubleshooting Tab. 2) Ensure all device users read and understand this notice. 3) Notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) Ensure proper instrument connections to the generator(s) and continue to follow all existing warnings and cautions found in user manuals 551400-15, USER MANUAL,SYS,P10,US,IS4000, 553873-07, USER MANUAL,I-A,MDR P10,IS4000-IS4200 and 554070-04, ADD,I-A,FORCE BIPOLAR,IS4000,IS4200. 5) Complete and return the acknowledgement form. 6) The recalling firm will follow-up with customers and schedule a software upgrade. 7) After the upgrade, inform all personnel that the software update/upgrade was completed. 8) If you have experienced this issue or require additional assistance, contact Technical Support: 800-876-1310, Option 1 (24/7) or customerservice@intusurg.com