The U.S. Food and Drug Administration (FDA) has announced a Class I recall for GE Healthcare’s resuscitation unit with blender, used with GE’s Giraffe and Panda infant warmers. 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.”
The FDA web site reports: “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 action impacts only field upgrade kits for GE Healthcare’s resuscitation systems with blender, which are installed in GE’s Giraffe and Panda infant warmers. The relevant resuscitation system upgrade kits were produced from April 2008 to September 2012.
GE Healthcare started the field correction on October 15, 2012, when it began notifying customers with affected units through an Urgent Medical Device Correction letter. The instructional, illustrated letter allowed hospital personnel to conduct immediate inspection and mitigation; follow up has been conducted to confirm receipt of the letter. GE field service engineers have inspected units at approximately 89% of identified customer sites. The remaining unconfirmed customers are being contacted and scheduled for inspection by GE field service technicians. No patient injuries have been reported with this issue to date.
For additional information, contact GE Healthcare Customer Service at 1-800-345-2700.