FDA Device recall Z-0653-2016
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41 by Intuitive Surgical, citing this correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula red….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0653-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-23 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
Reason
This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
Identifiers
| code_info | Model numbers: 470027-34, 470027-40, 470027-41. All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0653-2016%22
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