Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Reported: June 24, 2020 Initiated: April 28, 2020 #Z-2236-2020
Product Description
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Reason for Recall
Potential for certain Giraffe Incubators and Giraffe OmniBeds to 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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 5,883 units total
- Distribution
- Worldwide Distribution. US nationwide including US Virgin Islands, Australia, Austria, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Hong Kong, India, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latam, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, OMAN, State of Palestine, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.. Recalled by GE Healthcare, LLC. Units affected: 5,883 units total.
Why was this product recalled? ▼
Potential for certain Giraffe Incubators and Giraffe OmniBeds to 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2236-2020.
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