da Vinci Surgical System — Class II medical device recall Z-0283-2021
Terminated recall by Intuitive Surgical, Inc., reported 2020-11-04, distributed nationwide. One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of th
| Recall number | Z-0283-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2019-06-17 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2022-07-18 |
| Distributed | Nationwide (US) |
| Quantity | 1 systems |
| UPC / GTIN / UDI-DI | 00886874110898, 00886874114193 |
| Serial numbers | 432242, SK2137 |
| Model numbers | 372601-16, 381121-31 |
Product
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Reason for recall
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
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-0283-2021. 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.