The U.S. Food and Drug Administration (FDA) just announced that GE issued a recall of its Healthcare Resuscitation Systems in what the agency has classified a Class I recall.
A Class I recall is the agency’s most serious recall designation. These recalls involve situations In which there exists a reasonable probability that use of the recalled product will lead to serious adverse health consequences, even death.
The recalled GE devices are used to resuscitate infants and newborns and are also used to regulate body temperature. The device’s oxygen and air inlet fittings were reversed during assembly, which led to the recall. The following models are involved:
- Giraffe Warmer with Resuscitation System
- Panda Warmer with Resuscitation System
- Giraffe Stand-Alone Infant Resuscitation System
- Resuscitation System Upgrade Kits
- Panda Freestanding with Resuscitation System
These products are also referred as: Giraffe Warmer, Panda Warmer, Panda iRes Warmer, Giraffe and Panda IRes Infant Warmer, Giraffe and Panda Bag and Mask Resuscitation System, Giraffe and Panda Warmer TPiece, and T-Piece Resuscitation System. These recalled medical devices were manufactured from April 1, 2007 through October 31, 2013 and were distributed from October 1, 2007 through October 31, 2013. A complete listing of the model numbers involved may be accessed on the FDA website, by device type, at:
- Giraffe and Panda Warmer TPiece Resuscitation System: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/rescollection_2.cfm?id=124480&create_dt=2014-02-25
- Giraffe and Panda Bag and Mask Resuscitation System: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125258
- Giraffe and Panda iRes Infant Warmer: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125259
The issue with these medical devices is that the reversal of the oxygen and air wall inlet fittings, which may be found on the back panel of the recalled GE Healthcare Resuscitation Systems, may cause an interference in oxygen delivery. This may lead to inaccurate oxygen regulation in neonates (newborns), and may also cause hypoxia (low blood oxygen) or hyperoxia (high blood oxygen). This device defect may also lead to death in neonates, most particularly those newborns who are critically ill. Pre-term and low-birth weight babies are also at increased risk concerning morbidity and mortality.
On November 18, 2013 GE Healthcare issued an “Urgent Medical Device Correction” letter that included a return receipt, and was sent to all of its affected customers. The “Urgent Medical Device Correction” letter identified the recalled products, the problem, and safety instructions to be taken by the customer, as well as product correction. GE recommends its customers alert all potential users in their facilities about the safety notification and all related recommended actions. GE may be reached, toll-free at 1.800.345.2700, from Monday through Friday, 8:00 a.m. to 4:30 p.m.