The Recall Desk

FDA (Devices) recall action 65028

Hologic, Inc. recalled 2 products on 2013-05-22

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
2013-05-22
Critical
0
Units
3,067

Why these products were recalled

The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

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)··2013-05-22

    Hologic Fluoroscan Mini C-arm InSight Recalled for Inaccurate Irradiation Time Alarms

    Hologic is recalling Fluoroscan Mini C-arm InSight systems because the audible alarm for cumulative irradiation time is inaccurate. This may result in incorrect total irradiation time readings.

    Product
    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-05-22

    Hologic Fluoroscan Mini C-arm InSight2 Recalled for Inaccurate Irradiation Time Alarms

    Hologic is recalling Fluoroscan Mini C-arm InSight2 systems because the audible alarm and total cumulative irradiation time displays are inaccurate.

    Product
    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use,
    Category
    Distribution
    0 states