|[January 31, 2013]
Voluntary Field Correction Action Issued for GE Healthcare's Resuscitation Systems with Blender, Installed in GE Giraffe and Panda Infant Warmers
LAUREL, Md. --(Business Wire)--
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
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's 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
For additional information regarding this field action, please
contact GE Healthcare Customer Service at 1-800-345-2700.
About GE Healthcare
GE Healthcare provides transformational medical technologies and
services that are shaping a new age of patient care. Our broad expertise
in medical imaging and information technologies, medical diagnostics,
patient monitoring systems, drug discovery, biopharmaceutical
manufacturing technologies, performance improvement and performance
solutions services help our customers to deliver better care to more
people around the world at a lower cost. In addition, we partner with
healthcare leaders, striving to leverage the global policy change
necessary to implement a successful shift to sustainable healthcare
Our "healthymagination" vision for the future invites the world to
join us on our journey as we continuously develop innovations focused on
reducing costs, increasing access and improving quality and efficiency
around the world. Headquartered in the United Kingdom, GE Healthcare is
a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE
Healthcare employs more than 46,000 people committed to serving
healthcare professionals and their patients in more than 100 countries.
For more information about GE Healthcare, visit our web site at www.gehealthcare.com.
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