GE Healthcare Recalls Giraffe OmniBed Incubators Due to Oxygen Display Error
GE Healthcare is recalling Giraffe OmniBed infant incubators equipped with Servo Oxygen modules because they may deliver a different oxygen level than displayed.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant injury to vulnerable infant patients due to incorrect oxygen delivery.
Plain-English summary
GE Healthcare, LLC is recalling 5,883 units of Giraffe OmniBed infant incubators and warmers that have the optional Servo Oxygen module installed. The recall is due to a potential defect where the device may deliver a different environmental oxygen level than what is displayed on the device interface.
The affected products are distributed worldwide, including the United States, Canada, and numerous countries across Europe, Asia, and the Americas. The recall covers Giraffe Incubators with serial numbers HDHA through HDHQ, as well as specific Servo Oxygen Board spare part kits and upgrade kits.
Healthcare facilities should contact GE Healthcare for instructions on how to address the issue. Consumers and medical staff should verify if their devices match the affected serial numbers or part codes listed in the official recall notice.
The recalled product
- Product
- Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 5,883
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 (15)
- Giraffe Incubator: serial numbers HDHA through HDHQ
- Servo Oxygen Board spare part kit: 6600-0233-850
- Servo Oxygen upgrade kits: 6600-0678-800
- 6600-0678-801
- 6600-0678-802
- 6600-0678-803
- 66000849-800
- 6600-0849-801
- 6600-0849-802
- 6600-0849-803
- 6600-0866-800
- 6600-0866-801
- 6600-0867800
- 6600-0867-801
- M1142293 or M1142295.
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC 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.
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