Intuitive Surgical, Inc.: Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used

Hazard

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Details from the source

Reason for recall: Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury. Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France Quantity: 9 Lot/code info: System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962

UPC codes

00886874115404, 00886874110720

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.