Agency classClass IIOur severity:Severe FDA (Devices)·Z-1509-2017·Announced 2017-03-29

Ohmeda Medical Recalls Giraffe OmniBed Infant Incubators Due to Fire Risk

Ohmeda Medical is recalling Giraffe OmniBed infant incubators and warmers because certain power cords may overheat, posing a risk of fire or thermal injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a risk of fire and thermal injury, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk structural defects, warranting a Severe (4) rating.

Plain-English summary

Ohmeda Medical is recalling the Giraffe OmniBed, a combination infant incubator and radiant warmer, due to a safety defect in certain power cords. The affected power cords, manufactured by Electric-Cord and referred to as "Taller Bridge" power cords, have the potential to overheat.

The overheating of these power cords could result in fire, charring, smoke, or sparking at the connection point to the wall outlet. This malfunction poses a risk of thermal injury to patients or staff. The recall affects 5,993 units distributed worldwide, including 5,080 units in the United States and Puerto Rico, and 913 units in international markets such as the UK, Canada, and Brazil.

Consumers and healthcare facilities should stop using the affected units immediately. The specific lot numbers and serial numbers for the affected power cords are detailed in the attached spreadsheet referenced in the recall documentation. Users should contact Ohmeda Medical for instructions on how to replace the defective power cords or return the units.

The recalled product

Product: Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
Manufacturer: Ohmeda Medical
Category: Medical Device — Infant Incubator / Radiant Warmer
Hazard: fire
burn-injury

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 (1)

See Attached Spreadsheat

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Ohmeda Medical 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 11 products in this recall →

Same manufacturer · Ohmeda Medical

See all →

High
Giraffe Omnibed Infant Incubator Recalled for Inadequate Cleaning Instructions
FDA (Devices) · 2019-10-16
High
Ohmeda Medical Recalls Rotating IV Poles Due to Fall Risk
FDA (Devices) · 2018-04-04
Severe
Ohmeda-Ohio CarePlus Incubator Recall Due to Power Cord Overheating Risk
FDA (Devices) · 2017-03-29
Severe
Ohmeda Infant Warmer System Recalled Due to Overheating Power Cords
FDA (Devices) · 2017-03-29
Severe
Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk
FDA (Devices) · 2017-03-29

Same hazard · fire