Recall archive / FDA device enforcement
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (... — FDA record Z-0133-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 162
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0133-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 2, 2022
- Recall initiation date
- Sep 20, 2022
- Center classification date
- Oct 25, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.