The Recall Desk

FDA (Devices) recall action 68298

Hologic, Inc. recalled 2 products on 2014-06-11

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
2014-06-11
Critical
0
Units
14

Why these products were recalled

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

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)··2014-06-11

    Hologic Selenia Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2014-06-11

    Hologic M-IV Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
    Category
    Distribution
    4 states