The Recall Desk
HighFDA (Devices)·Z-0539-2020·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential patient fall) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Healthcare, LLC is recalling 7,814 units of the Giraffe OmniBed Carestation and Giraffe OmniBed Carestation CS1 infant warmers. The affected model numbers are 2082844-001-XXXXXX and 2082844-001-XXXXXXXX. The recall covers units distributed worldwide.

The recall was issued because the bedside panels and portholes on these devices can appear closed without being properly latched. This defect creates a potential risk of patient falls.

Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify a particular action for consumers, as these are medical devices used in clinical settings.

The recalled product

Product
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
Manufacturer
GE Healthcare, LLC
Affected units
7,814

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Giraffe OmniBed Carestation
  • Model Numbers: 2082844-001-XXXXXX Giraffe OmniBed Carestation CS1

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →