FDA Device recall Z-2835-2018
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller
- FDA Device
- Class II
- ongoing
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller by Intuitive Surgical, citing an Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2835-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-05-17 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | n/a |
Product
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Reason
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.
Identifiers
| code_info | UDI Number: 00886874114193. Serial Number: SK1703. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2835-2018%22
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