The Recall Desk

FDA (Devices) recall action 83692

Elekta Inc recalled 2 products on 2019-10-02

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
2019-10-02
Critical
0
Units
79

Why these products were recalled

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

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)··2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 49 Monaco RTP Systems because unintentional changes to electron density settings may cause incorrect dose calculations for radiation therapy plans.

    Product
    Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans…
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

    Product
    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment…
    Category
    Distribution
    6 states