The Recall Desk

FDA (Devices) recall action 81224

GE Healthcare, LLC recalled 6 products on 2018-11-28

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2018-11-28
Critical
0
Units
10,344

Why these products were recalled

Potential electric leakage affecting the user.

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.

1–6 of 6

  • HighFDA (Devices)··2018-11-28

    GE Healthcare Recalls Giraffe OmniBed Neonatal Incubators Due to Electric Leakage

    GE Healthcare is recalling 1,724 Giraffe OmniBed Carestation neonatal incubators worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-11-28

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Electric Leakage

    GE Healthcare is recalling 1,724 Panda Freestanding Infant Warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-11-28

    GE Healthcare Recalls Panda iRes Infant Radiant Warmers Due to Electric Leakage

    GE Healthcare is recalling 1,724 Panda iRes Infant Radiant Warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-11-28

    GE Healthcare Recalls Giraffe Incubator Carestations Due to Electric Leakage

    GE Healthcare is recalling 1,724 Giraffe Incubator Carestations worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-11-28

    GE Healthcare Recalls Giraffe Infant Warmers Due to Electric Leakage Risk

    GE Healthcare is recalling 1,724 Giraffe infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
    Category
    Distribution
    0 states