Z-1819-2017Class II

da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000...

Name: Z-1819-2017 da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000...
Creator: Intuitive Surgical, Inc.
Published: 2017-03-31
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2017-03-31 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of 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... on 2017-03-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1819-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-31
Posted: 2017-04-13
Terminated: 2017-07-28
Recalling firm: Intuitive Surgical, Inc.
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.
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: Firm sent e-mails on 3-17-17 to affected sites instructing them to STOP USE of the XI Suction Irrigator and RMA. and return all unused Xi Suction/irrigation instruments for credit. A formal letters was sent to affected sites on March 31, 2017. Letters advised of the reason for recall with details on product name and product number. Letters requested that any unused devices be returned to Intuitive via the standard RMA process. All personnel who use the Da Vinci system should be made aware of the issue. Response form should be completed online or by returning copy enclosed with the letter.
Quantity in commerce: 15 x 6 packs (90 units)
Distribution: US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1819-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-13

Product code NAY

K162973Class IIEndoWrist Suction IrrigatorIntuitive Surgical, Inc. / cleared 2017-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)