FDA Device recall Z-1819-2017
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument by Intuitive Surgical, citing intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1819-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-31 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | AL, CO, KS, NV, NY, TX |
Product
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.
Reason
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
Identifiers
| code_info | All |
|---|
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-1819-2017%22
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