Z-2236-2020 Class II Terminated
FDA device recall Z-2236-2020 was initiated by GE Healthcare, LLC on April 28, 2020 and is designated Class II. 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… The recall status is terminated (terminated September 23, 2024). Affected quantity: 5,883 units total.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- April 28, 2020
- Termination Date
- September 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,883 units total
Product Description
Reason for Recall
Distribution Pattern
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