The Recall Desk

FDA (Devices) recall action 83096

GE Healthcare, LLC recalled 2 products on 2019-08-07

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
2019-08-07
Critical
0
Units
98

Why these products were recalled

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

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)··2019-08-07

    GE Senographe Pristina Mammography Systems Recalled for Biopsy Positioner Slippage

    GE Healthcare is recalling 82 Senographe Pristina mammography systems because the biopsy positioner may slip when the gantry is rotated during a procedure.

    Product
    GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammograp
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2019-08-07

    GE Pristina Serena Breast Biopsy Accessory Recalled for Slippage Risk

    GE Healthcare is recalling 16 Pristina Serena breast biopsy accessories because the positioner may slip when the machine rotates during a procedure.

    Product
    GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
    Category
    Distribution
    13 states