The Recall Desk

FDA (Devices) recall action 81010

Varian Medical Systems recalled 2 products on 2018-10-10

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
2018-10-10
Critical
0
Units
391

Why these products were recalled

Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-10-10

    Varian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling TrueBeam and EDGE radiotherapy systems because a software anomaly can cause treatments to occur without intended respiratory gating.

    Product
    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in…
    Category
    Distribution
    25 states
  • HighFDA (Devices)··2018-10-10

    Varian VitalBeam Radiotherapy Systems Recalled for Gating Anomaly

    Varian Medical Systems is recalling VitalBeam Radiotherapy Delivery Systems due to a software anomaly that may result in treatment without intended respiratory gating.

    Product
    VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Distribution
    25 states