Z-0315-2017Class II

da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The...

Name: Z-0315-2017 da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The...
Creator: Intuitive Surgical, Inc.
Published: 2016-10-05
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2016-10-05 / Terminated / root cause: software

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control... on 2016-10-05. FDA classified it as Class II and gives the reason as "Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances". 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-0315-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-10-26
Terminated: 2017-05-01
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters were sent on October 12, 2016 by traceable method to all affected customers. Letters notify customers of the issue and provided instructions to prevent it from happening until ISI software can install new software upgrade in 1st Q 2017.
Quantity in commerce: 677 devices
Distribution: Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Product codes and lots: All systems manufactured with or upgraded to P5 software.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0315-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0315-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-26

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

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)