Z-2341-2018Class II

da Vinci X Surgical System, Model IS4200

Name: Z-2341-2018 da Vinci X Surgical System, Model IS4200
Creator: Intuitive Surgical, Inc.
Published: 2018-03-07
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-03-07 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200)... on 2018-03-07. FDA classified it as Class II and gives the reason as "Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2341-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-07
Posted: 2018-07-02
Terminated: 2020-07-29
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) 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, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave 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. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intuitive Surgical, Inc. sent a Recall letters dated 3/7/2018 to affected customers via FedEx. The letter identified the affected product problem, risk to health, affected serial numbers, the action the firm will be taking, and the actions to be taken by the customer.
Quantity in commerce: 108 ACJ's on 35 surgical systems
Distribution: US Nationwide AR, CA, FL, GA, IL, IA, MN, MS, NE, OK, TN, and TX. Foreign distribution was made to Australia, Austria, Finland, France, Germany, Italy, Netherlands, Spain, and United Kingdom.
Product codes and lots: System S/N SL0008, ACJ S/N's P117154256, P117154263, P117154281, P117154286; System S/N SL0012, ACJ S/N's P117154260, P117154297, P117154298, P117154308; System S/N SL0013, ACJ S/N's P117154251, P117154255, P117154257, P117154305; System S/N SL0015, ACJ S/N's P117154274, P117154276, P117154289, P117154290; System S/N SL0016, ACJ S/N's P117154259, P117154291, P117154306, P117154307; System S/N SL0017, ACJ S/N's P117154261, P117154269, P117154277, P117154296; System S/N SL0018, ACJ S/N's P117194009, P117194017, P117194037; System S/N SL0019, ACJ S/N's P117154267, P117154283, P117154294, P117154302; System S/N SL0020, ACJ S/N's P117194008, P117194050, P117194060, P117194078; System S/N SL0021, ACJ S/N's P117194063, P117194064, P117194081, P117194083; System S/N SL0028, ACJ S/N's P117154279, P117154285, P117154292, P117154300; System S/N SL0034, ACJ S/N's P117154264, P117154275, P117154304; System S/N SL0035, ACJ S/N's P117194016, P117194019, P117194070, P117194093; System S/N SL0036, ACJ S/N's P117194025, P117194073, P117241990; System S/N SL0037, ACJ S/N's P117194006, P117194036, P117194056, P117194058 System S/N SL0038, ACJ S/N's P117241971, P117241993; System S/N SL0039, ACJ S/N's P117194013, P117194024, P117194031, P117194032; System S/N SL0040, ACJ S/N's P117194046, P117194061, P117194088, P117194094; System S/N SL0041, ACJ S/N's P117194027, P117194040, P117194043, P117194049; System S/N SL0042, ACJ S/N's P117154288, P117194015, P117194052, P117194090; System S/N SL0043, ACJ S/N P117241988; System S/N SL0044, ACJ S/N's P117194007, P117194085, P117241978; System S/N SL0045, ACJ S/N's P117241965, P117241970, P117241982, P117241984; System S/N SL0046, ACJ S/N's P117194014, P117241964, P117241976, P117241980; System S/N SL0047, ACJ S/N's P117194020, P117194048, P117194067, P117194074 System S/N SL0048, ACJ S/N's P117194004, P117194072, P117200171; System S/N SL0052, ACJ S/N's P117241977, P117241979, P117241986, P117241991; System S/N SL0053, ACJ S/N P117241966; System S/N SL0055, ACJ S/N P117283217; System S/N SL0056, ACJ S/N P117283216; System S/N SL0060, ACJ S/N P117241972; System S/N SL0063, ACJ S/N P117241968; System S/N SL0070, ACJ S/N's P117194028, P117194092; System S/N SL0071, ACJ S/N's P117194018, P117283218; and System S/N SL0073. ACJ S/N P117283214.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2341-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2341-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02

Product code NAY

K171294Class IIda Vinci X Surgical SystemIntuitive Surgical, Inc. / cleared 2017-05-26

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)