The Recall Desk

FDA (Devices) recall action 79848

Visaris DOO recalled 3 products on 2018-05-23

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-05-23
Critical
0
Units
—

Why these products were recalled

A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2018-05-23

    Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

    Visaris DOO is recalling specific diagnostic X-ray systems due to a potential failure in the tube arm suspension that could cause the arm to descend uncontrollably.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this syste
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2018-05-23

    Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and patient injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2018-05-23

    Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this syste
    Category
    Distribution
    6 states