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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Voluntary Field Correction Action Issued for GE Healthcare’s Resuscitation Systems with Blender Installed in GE Giraffe and Panda Infant Warmers

 

Contact
Consumer:
1-800-345-2700

Media:
Annette Busateri
GE Healthcare
+1-262-442-0966

FOR IMMEDIATE RELEASE - January 31, 2013 -On October 15, 2012, GE Healthcare initiated a voluntary field corrective action of the field upgrade kit for GE Healthcare’s resuscitation systems with blender, installed in GE Giraffe and Panda infant warmers.

The field upgrade kit for GE Healthcare’s resuscitation unit with blender, used with GE’s Giraffe and Panda infant warmers, may impact patient safety. The oxygen and air wall inlet fittings and/or labels on the back panel may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. The settings of the blender knob would no longer be accurate.

This voluntary field correction only impacts field upgrade kits for GE Healthcare’s resuscitation systems with blender, installed in GE’ Giraffe and Panda infant warmers. The affected resuscitation system upgrade kits were manufactured from April 2008 to September 2012.

GE Healthcare initiated the field correction on October 15, 2012, and began notifying customers with affected units through an Urgent Medical Device Correction letter, which provided instructions and illustrations to allow hospital personnel to conduct immediate inspection and mitigation, and follow up has been conducted to confirm their receipt of the letter. GE field service engineers have inspected units at approximately 89% of the identified customer sites. The remaining unconfirmed customers are being contacted and scheduled for inspection by GE field service technicians. To date, no patient injuries have been reported with this issue.

The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”

For additional information regarding this field action, please contact GE Healthcare Customer Service at 1-800-345-2700.

 

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