The Recall Desk

FDA (Devices) recall action 80302

Fx Solutions recalled 2 products on 2018-07-25

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
2018-07-25
Critical
0
Units
276

Why these products were recalled

Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

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

  • ModerateFDA (Devices)··2018-07-25

    Fx Solutions Proton Beam Therapy Heads Recalled for Blister Breach

    Fx Solutions is recalling specific proton beam therapy heads due to a breach in the external blister packaging.

    Product
    Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-07-25

    Fx Solutions Offset Heads Recalled for Blister Breach

    Fx Solutions is recalling specific lots of Humelock Offset Heads due to a breach in the external blister packaging.

    Product
    Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam…
    Category
    Distribution
    0 states