Agency classClass IIOur severity:Severe FDA (Devices)·Z-1511-2017·Announced 2017-03-29

Ohmeda Infant Warmer System Recalled Due to Overheating Power Cords

Ohmeda Medical is recalling IWS Infant Warmer Systems because certain power cords may overheat, posing a fire and thermal injury risk.

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 is classified as FDA Class II and involves a risk of fire and thermal injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects in medical devices.

Plain-English summary

Ohmeda Medical is recalling the IWS Infant Warmer System due to a safety hazard involving specific 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 units in the United States (nationwide and Puerto Rico) and 913 units in other countries such as the UK, Canada, and Brazil. The product is a medical device used to provide controlled infrared heat to neonates who are unable to thermoregulate on their own.

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 devices and contact Ohmeda Medical for instructions on repair or replacement.

The recalled product

Product: IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They…
Manufacturer: Ohmeda Medical
Category: Medical Device — Neonatal Care
Hazard: fire
burn-injury
overheating

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 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