Recall Z-2236-2020 ยท FMZ Incubator, Neonatal
GE Healthcare, LLC
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
| Date | Apr 28, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE Healthcare notified customers on about 04/28/2020 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed 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 the device. Instructions included that if the Giraffe Incubator or Giraffe OmniBed device was manufactured before 2012 AND has the oxygen sensor part number M-43GE installed, the Servo Oxygen feature will need to be di |
| Quantity | 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, Gree |
| FDA record | Open on fda.gov |