Agency classClass IIOur severity:High FDA (Devices)·Z-2236-2020·Announced 2020-06-24

GE Healthcare Recalls Giraffe Incubators with Servo Oxygen Module

GE Healthcare is recalling Giraffe Incubators with Servo Oxygen modules because they may deliver different oxygen levels 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device potentially delivering incorrect oxygen levels, which is a risk-of-harm product where injury has not yet been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling Giraffe Incubators with installed Servo Oxygen modules. The recall involves 5,883 units distributed worldwide, including the United States and numerous international locations. The affected devices are identified by specific serial numbers and part kit codes.

The recall is due to a potential for the devices to deliver a different environmental oxygen level than what is displayed by the device. This discrepancy could occur if the optional Servo Oxygen Module is installed.

Healthcare facilities should contact GE Healthcare for instructions on how to address the issue. The source text does not specify a consumer action for general public, as these are medical devices used in clinical settings.

The recalled product

Product: Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Infant Incubator
Hazard: incorrect-oxygen-level
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 HDGA through HDGQ
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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Same hazard · incorrect oxygen level