The Recall Desk

FDA (Devices) recall action 74607

Vision RT Ltd recalled 2 products on 2016-08-31

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
2016-08-31
Critical
0
Units
94

Why these products were recalled

Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2016-08-31

    Vision RT TrueBeam and Edge Radiotherapy Systems Recalled for Parameter Errors

    Vision RT Ltd is recalling 47 TrueBeam and EDGE radiotherapy systems because unintended changes to couch rotation parameters were discovered during patient set-up.

    Product
    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-08-31

    Vision RT AlignRT Plus System Recalled for Unintended Couch Parameter Changes

    Vision RT Ltd is recalling 47 AlignRT Plus systems because unintended changes to couch rotation parameters were discovered during patient set-up. No patient harm was reported.

    Product
    AlignRT¿ Plus [private label-OSMS] K123371: 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 radiation delivery.
    Category
    Distribution
    0 states