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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci X Surgical System, Model IS4200

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  Class 2 Device Recall da Vinci X Surgical System, Model IS4200 see related information
Date Initiated by Firm March 07, 2018
Create Date July 02, 2018
Recall Status1 Terminated 3 on July 29, 2020
Recall Number Z-2341-2018
Recall Event ID 80249
510(K)Number K171294  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Marylyn Kuverji
408-523-2667
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc.
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