Intuitive Surgical, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1819-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 31, 2017

Date Posted: April 19, 2017

Recall Number: Z-1819-2017

Event ID: 76911

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.

Status: Terminated

Product Quantity: 15 x 6 packs (90 units)

Code Information:

All

Distribution Pattern:

US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX

Voluntary or Mandated:

Voluntary: Firm initiated