da Vinci X — Class II medical device recall Z-0133-2023
Ongoing recall by Intuitive Surgical, Inc., reported 2022-11-02, distributed in AK, AL, AZ, CA, CO, FL, GA, IA…. Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments instal
| Recall number | Z-0133-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2022-09-20 |
| Classified | 2022-10-25 |
| Reported by FDA | 2022-11-02 |
| Distributed | AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NV, OH, PA, SC, TN, TX, WA, WI |
| Quantity | 162 |
| UPC / GTIN / UDI-DI | 00886874110720, 00886874110744, 00886874110898, 00886874115343, 00886874115374, 00886874115404 |
| Model numbers | 610092-738 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0133-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.