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Intuitive Surgical, Inc. Recall 90826

Description: da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)

Intuitive Surgical, Inc. Recall 90826 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0133-2023
Event ID90826
Event Descriptionda Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Product TypeDevices
DistributionUS: 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
Recall ReasonInadvertent 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
Device Classification20221102
Device Code InfoSoftware 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
Center Classification Date20221025
Recall Initiation Date20220920
Recalling FirmIntuitive Surgical, Inc.
Initial Notification Letter
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