The company said when the Giraffe Incubator with a Servo Control Oxygen System or Giraffe OmniBed is powered "on", or in the event that there is a recovery from a power failure, any manual settings entered by the clinician for the oxygen set point or radiant heater set point may be overwritten.
This may result in changes to the warmer (Giraffe OmniBed only) or oxygen settings, which may pose a risk to patients using the device.
GE Healthcare initiated the field correction and began to notify customers with the affected units through an Urgent Medical Device Correction letter.
No customer complaints or patient injuries have been reported with regards to the issue till date, according to the company.
Giraffe Incubators without the Servo Control Oxygen System are not impacted by voluntary field corrective action.
