The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1504-2017·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 is classified as FDA Class II and involves a hazard that could result in fire and thermal injury, which aligns with the rubric criteria for a Severe rating (score 4) involving significant injury reports or structural defects.

Plain-English summary

Ohmeda Medical is recalling the Giraffe OmniBed, a combination infant incubator and warmer, 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 result in fire, charring, smoke, or sparking at the point where the power cord connects to the wall outlet, which could cause thermal injury to patients or staff.

The recall affects 5,993 units of the Giraffe OmniBed. These devices are used to provide controlled heat to neonates who are unable to regulate their own body temperature. The affected units were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as in the Bahamas, UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela.

Healthcare facilities and users of the Giraffe OmniBed should immediately stop using the affected power cords and contact Ohmeda Medical for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both…
Manufacturer
Ohmeda Medical
Category
Medical Device — Infant Incubator
Hazard

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 →

Related recalls

Same manufacturer · Ohmeda Medical

See all →

Same hazard · fire

See all →

Similar recalls