Agency classClass IIOur severity:Severe FDA (Devices)·Z-2235-2020·Announced 2020-06-24

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.

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, 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
Category: Medical Device — Infant Incubator
Hazard: incorrect-oxygen-level
device-malfunction
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

Same manufacturer · GE Healthcare, LLC

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