Intuitive Surgical, Inc.: 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.

Recall number

Z-2341-2018

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.

Status

Terminated

Initiated

2018-03-07

Posted

not on file

Terminated

2020-07-29

Reason

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

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K171294"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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