The da Vinci Xi Surgical System — Class II medical device recall Z-2835-2018
Ongoing recall by Intuitive Surgical, Inc., reported 2018-08-22. An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may res
| Recall number | Z-2835-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-05-17 |
| Classified | 2018-08-16 |
| Reported by FDA | 2018-08-22 |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00886874114193 |
| Serial numbers | SK1703 |
| Model numbers | 372601-16 |
Product
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Reason for recall
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
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-2835-2018. 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.