GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly

AUDIENCE: Risk Manager, Biomedical Engineer

ISSUE: The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. These recalled products may interfere with oxygen delivery,  resulting in inaccurate oxygen regulation in newborns (neonates), and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality. The affected products were manufactured from April 1, 2007 through October 31, 2013 and distributed from October 1, 2007 through October 31, 2013. The recall effected the folloiwng models: Giraffe Warmer with Resuscitation System, Panda Warmer with Resuscitation System, Giraffe Stand-Alone Infant Resuscitation System, Resuscitation System Upgrade Kits, and the Panda Freestanding with Resuscitation System.

See the Recall Notice for more information.

BACKGROUND: On November 18, 2013 GE Healthcare sent an Urgent Medical Device Correction letter, with a return receipt, to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. The firm recommends their customers alert all potential users in their facilities about the safety notification and the recommended actions.

RECOMMENDATION: The firm recommends their customers alert all potential users in their facilities about the safety notification and the recommended actions.

For questions or concerns regarding this recall, please call the company at 1-800-345-2700, Monday – Friday, 8:00 am – 4:30 pm.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/28/2014 - Recall Notice - FDA]