Ohmeda Medical recalls Giraffe Omnibeds (2000-2011) due to infection risk from debris buildup if canopy seals aren't cleaned properly. The device combines an incubator and warmer for neonates.
GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
Ohmeda Medical is recalling Giraffe Omnibeds from 2000 to 2011 because improper cleaning of the canopy seals can cause debris buildup, leading to infection risks for infants. This is a safety issue for healthcare providers using the device in neonatal care.
Debris can build up around the canopy seal if it's not cleaned properly, creating a potential infection source. The current cleaning instructions don't specify removing the canopy seal before cleaning, which leads to debris accumulation.
Healthcare providers using Giraffe Omnibeds for neonatal care are most at risk, as the device is used for infants who cannot regulate their body temperature.
Check for Giraffe Omnibeds with serial numbers from HDGD00001 to HDGQ50183 that were shipped between 2000 and 2011.
Look for the serial number on the device, which should be between HDGD00001 and HDGQ50183 for affected units.
The recall is happening because healthcare professionals reported debris buildup around the canopy seal when not cleaned properly, which can lead to infection risks for infants.
Your Giraffe Omnibed is affected if it was shipped between 2000 and 2011 with a serial number from HDGD00001 to HDGQ50183.
The recall record does not specify a remedy, so you should contact Ohmeda Medical directly for guidance on next steps.
We’ve drafted a message you can send Ohmeda Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0041-2020 — Ohmeda Medical Ohmeda Medical Hello, I own a Ohmeda Medical that is covered by recall Z-0041-2020 from Ohmeda Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
