da Vinci Xi EndoWrist Suction Irrigator — Class II medical device recall Z-1819-2017
Terminated recall by Intuitive Surgical, Inc., reported 2017-04-19, distributed in AL, CO, KS, NV, NY, TX. Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suc
| Recall number | Z-1819-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2017-03-31 |
| Classified | 2017-04-13 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-07-28 |
| Distributed | AL, CO, KS, NV, NY, TX |
| Reason classes | software |
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 for recall
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.
Machine access
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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.