Agency classClass IOur severity:Severe FDA (Devices)·Z-1051-2013·Announced 2013-04-17

GE Healthcare Recalls Giraffe OmniBed and Incubator Units for Display Errors

GE Healthcare is recalling 679 Giraffe OmniBed and Incubator units because display boards may randomly overwrite stored information and set points upon power up or recovery from a power failure.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 I, which the rubric defines as a situation where use of the product may cause serious adverse health consequences or death. The defect involves the overwriting of critical oxygen and heater set points for neonatal patients.

Plain-English summary

GE Healthcare, LLC is recalling 679 units of the Giraffe OmniBed and Giraffe Incubator (p/n 6600-0723-700, rev A and B). The affected devices are combination infant incubators and warmers. The recall covers units distributed worldwide, including in the United States and numerous international countries.

The recall is being issued because the neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure. This defect could result in the device not maintaining the intended settings for the infant.

Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and GE Healthcare should be contacted for instructions on repair or replacement.

The recalled product

Product: Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Neonatal Care
Hazard: device-malfunction
oxygen-setpoint-error
heater-setpoint-error
Affected units: 679

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 (20)

OmniBed Serial Numbers: HDGR52546
HDGR52736
HDGR52802
HDGR52861
HDGR52910
HDGR52958
HDGR53007
HDGR53058
HDGR53110
HDGR53185
HDGR52547
HDGR52737
HDGR52803
HDGR52862
HDGR52911
HDGR52959
HDGR53008
HDGR53059
HDGR53112
HDGR53186

Distribution

Distributed in 29 states:

Same manufacturer · GE Healthcare, LLC

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