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Nationwide Voluntary Field Correction Action Issued for GE Healthcare’s
Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control System
FOR IMMEDIATE RELEASE - April 22, 2013 - On January 8, 2013, GE Healthcare initiated a nationwide voluntary field corrective action of the Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed, which were manufactured from August 1, 2012 through December 20, 2012. Giraffe Incubators without a Servo Control Oxygen System are not impacted.
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 (values 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 this device. An inaccurate setting for temperature or oxygen regulation may predispose patients to high or low temperature or high or low environmental oxygen delivery, depending on the default parameters. These conditions would be evident through typical patient monitoring in use by clinicians (e.g., vital sign monitoring, pulse oximetry, and skin temperature probes).
GE Healthcare initiated the field correction on January 8, 2013, and began notifying customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and provides instructions to mitigate the issue. Follow up on this letter is being conducted to confirm receipt and GE field service engineers are being deployed to inspect all affected units. Any outstanding customers are being contacted and scheduled for an upgraded by a GE field service technician. To date, no customer complaints or patient injuries have been reported with regards to this issue.
For additional information regarding this field action, please contact GE Healthcare’s Customer Service line (24 hours a day, 7 days a week) at 1-800-345-2700.
Note to editor:
Any adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.