The Recall Desk

FDA (Devices) recall action 84077

GE Healthcare, LLC recalled 4 products on 2019-12-11

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2019-12-11
Critical
1
Units
54,399

Why these products were recalled

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

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.

1–4 of 4

  • HighFDA (Devices)··2019-12-11

    GE Healthcare Recalls Giraffe OmniBed Carestations Due to Latching Defect

    GE Healthcare is recalling Giraffe OmniBed Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-12-11

    GE Healthcare Recalls Giraffe Incubator Carestations Due to Latch Defect

    GE Healthcare is recalling Giraffe Incubator Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
    Category
    Distribution
    0 states