The Recall Desk

FDA (Devices) recall action 82485

GE Healthcare, LLC recalled 2 products on 2019-07-17

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
2019-07-17
Critical
0
Units
37,188

Why these products were recalled

The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.

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

  • ModerateFDA (Devices)··2019-07-17

    GE Healthcare Recalls Panda Infant Radiant Warmers Due to Bedside Panel Cracking

    GE Healthcare is recalling 28,094 Panda Infant Radiant Warmers because the bedside panels and latch areas can crack or break if the unit is moved using them instead of the designated handles.

    Product
    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or
    Category
    Distribution
    53 states
  • ModerateFDA (Devices)··2019-07-17

    GE Healthcare Recalls Giraffe Infant Radiant Warmers Due to Panel Cracking

    GE Healthcare is recalling 9,094 Giraffe Infant Radiant Warmers because bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the designated handles.

    Product
    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment
    Category
    Distribution
    53 states
GE Healthcare, LLC recalled 2 products on 2019-07-17 · The Recall Desk