FDA Device recall Z-0283-2021
da Vinci Surgical System, IS 4000
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of da Vinci Surgical System, IS 4000 by Intuitive Surgical, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0283-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-17 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
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.
Identifiers
| code_info | IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0283-2021%22
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