Agency classClass IIOur severity:Severe FDA (Devices)·Z-1501-2017·Announced 2017-03-29

Ohmeda Giraffe Exam Light Recalled Due to Power Cord Overheating Risk

Ohmeda Medical is recalling Giraffe Exam Lights because certain power cords may overheat, posing a risk of fire, smoke, 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 risk of fire and thermal injury, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk hazards, warranting a Severe classification.

Plain-English summary

Ohmeda Medical is recalling specific Giraffe Exam Lights due to a defect in the power cords. The affected power cords, manufactured by Electric-Cord and referred to as 'Taller Bridge' power cords, have the potential to overheat. This overheating can occur where the power cord connects to the wall outlet.

The recall involves 5,993 units distributed worldwide, including 5,080 in the United States (nationwide and Puerto Rico) and 913 outside the US. The product is designed to mount on accessory railings of the Giraffe OmniBed, incubators, and warmers, excluding Panda and Giraffe Warmers.

The overheating of the power cord could result in fire, charring, smoke, or sparking. These conditions could cause thermal injury to patients or staff. Consumers and healthcare facilities should stop using the affected units and contact Ohmeda Medical for instructions on repair or replacement.

The recalled product

Product: Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the…
Manufacturer: Ohmeda Medical
Category: Medical Device — Exam Lights
Hazard: fire
thermal-injury
smoke

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 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
Severe
Ohmeda Medical Recalls Giraffe Incubators Due to Power Cord Overheating
FDA (Devices) · 2017-03-29

Same hazard · fire