Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 57 recalls
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result i…
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled moti…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic end…
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.