The Recall Desk

FDA (Devices) recall action 74585

Varian Medical Systems, Inc. recalled 2 products on 2016-07-20

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-07-20
Critical
0
Units
—

Why these products were recalled

Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].

Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].

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

1–2 of 2

  • HighFDA (Devices)··2016-07-20

    Varian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors

    Varian Medical Systems is recalling AlignRT Plus systems because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radi
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-07-20

    Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes

    Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automaticall
    Category
    Distribution
    0 states