Class I - other

IS4000-XI, IS3000-SI and SI-E, concerning the EndoWrist sealant, references 410322 and 480322.

The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVESURGICAL endoscopic instruments during urological surgical procedures, general laparoscopic surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures . The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon's console, a patient car and a vision car, it also includes the endoscopes and instrumentosendowrist.

IS4000 and p5X, software version P5

The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVESURGICAL endoscopic instruments during urological surgical procedures, general laparoscopic surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures . The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon console, a patient car and a vision car, including endoscopes and endowrist instruments.

DA VINCI XI, serial SK0954

The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVE SURGICAL endoscopic instruments during urological surgical procedures, laparoscopic general surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures. The system can also be used with adjunctive mediastinotomy to perform coronary artery bypass during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon's console, a patient's car and a vision car, it also includes ENDOWRIST endoscopes and instruments.

Surgical stapler

Surgical Robot Surgical Unit

Surgical Robot Surgical Unit

Reducer

Surgical stapler

Model: INS-400180 Version 12, Affected: 20 lots

Model: , Affected:

Model: INS-400172, Affected: M10120815, M10120817, M10120831, M10120913,M10120918,M10121008,M10121024,M10121120,M10121123,M10121203,M10121210,M10121215,M10130220,M10130222,M10130311,M10130315,M10130327,M10130411

Model: INS-420179 and INS-400179, Affected: -09 and -10

Model: All models, Affected: All units

Model: INS-950093-05, Affected:

Model: da Vinci S, Si and Si-e Patient Side cart, Affected:

Model: Models: INS-420006, INS-420194, INS-400006, INS-400194, Affected: Manufactured between July 2007 and October 2011

Model: Product Codes: INS-428061, INS-428062, INS-428071, INS-428072, Affected: All lots

Model: All models, Affected: All units

Model: 428050-12, 428050-13, 428050-14, 428053-12, 428053-15, 428055-12, 428055-13, 428056-12, 428056-13, 428058-12, 428058-13, 428059-12, 428059-13, 428080-04, 428080-05, 428088-12, 428088-13, 428093-12, 428093-13, Affected: All lots

Model: INS-IS2000,INS-IS3000,INS-IS4000, Affected:

Model: da Vinci® Xi EndoWrist Stapler Release Kit, Affected:

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