Health product recall

OminBed & Giraffe Incubator (2020-05-06)

Starting date:
May 6, 2020
Posting date:
May 15, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73119

Last updated: 2020-05-15

Affected Products

  1. OminBed
  2. Giraffe Incubator

Reason

GE Healthcare has become aware that certain Giraffe Incubators and Giraffe OmniBeds manufactured before 2012 can deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed in your device. The Servo Oxygen Module automatically regulates oxygen that is provided internally by the device. Standard pulse oximetry monitoring will detect patient oxygen level changes and therefore this issue should only result in temporary hypoxia or hyperoxia. There have been no injuries reported as a result of this issue. THERE HAVE BEEN NO INJURIES REPORTED AS A RESULT OF THIS ISSUE.

Affected products

A. OminBed

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • OmniBed
Companies
Manufacturer
Datex-Ohmeda, Inc
9900 Innovation Drive
Wauwatosa
53226
Wisconsin
UNITED STATES

B. Giraffe Incubator

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • Giraffe Incubator
Companies
Manufacturer
Datex-Ohmeda, Inc
9900 Innovation Drive
Wauwatosa
53226
Wisconsin
UNITED STATES

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