da Vinci X Surgical System, IS4200 recalled by Intuitive Surgical

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.

Nationwide AlaskaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisIndianaKansasMassachusettsMichiganMississippiNew YorkOhioPennsylvaniaTennesseeTexas