Reported Jul 11, 2018 · Terminated
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci X Surgical System, Model IS4200
- Product UsageThe 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
- Lot codes and dates
33 of 33 products
Products covered by this recall # Product as published 1 System S/N SL0008, ACJ S/N's P117154256, P117154263, P117154281, P117154286 2 System S/N SL0012, ACJ S/N's P117154260, P117154297, P117154298, P117154308 3 System S/N SL0013, ACJ S/N's P117154251, P117154255, P117154257, P117154305 4 System S/N SL0015, ACJ S/N's P117154274, P117154276, P117154289, P117154290 5 System S/N SL0016, ACJ S/N's P117154259, P117154291, P117154306, P117154307 6 System S/N SL0017, ACJ S/N's P117154261, P117154269, P117154277, P117154296 7 System S/N SL0018, ACJ S/N's P117194009, P117194017, P117194037 8 System S/N SL0019, ACJ S/N's P117154267, P117154283, P117154294, P117154302 9 System S/N SL0020, ACJ S/N's P117194008, P117194050, P117194060, P117194078 10 System S/N SL0021, ACJ S/N's P117194063, P117194064, P117194081, P117194083 11 System S/N SL0028, ACJ S/N's P117154279, P117154285, P117154292, P117154300 12 System S/N SL0034, ACJ S/N's P117154264, P117154275, P117154304 13 System S/N SL0035, ACJ S/N's P117194016, P117194019, P117194070, P117194093 14 System S/N SL0036, ACJ S/N's P117194025, P117194073, P117241990 15 System S/N SL0037, ACJ S/N's P117194006, P117194036, P117194056, P117194058 System S/N SL0038, ACJ S/N's P117241971, P117241993 16 System S/N SL0039, ACJ S/N's P117194013, P117194024, P117194031, P117194032 17 System S/N SL0040, ACJ S/N's P117194046, P117194061, P117194088, P117194094 18 System S/N SL0041, ACJ S/N's P117194027, P117194040, P117194043, P117194049 19 System S/N SL0042, ACJ S/N's P117154288, P117194015, P117194052, P117194090 20 System S/N SL0043, ACJ S/N P117241988 - Amount recalled
- 108 ACJ's on 35 surgical systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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