Z-2341-2018 Class II Terminated

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.

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.

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.