Home / Recalls / Intuitive Surgical, Inc. / Z-0133-2023

Z-0133-2023 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

FDA device recall Z-0133-2023 was initiated by Intuitive Surgical, Inc. on Sep 20, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 162.

Recall Details

Product Type: Devices
Report Date: Nov 2, 2022
Initiation Date: Sep 20, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 162

Product Description

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

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 Pattern

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

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0133-2023
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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