Medical Devices

GE Healthcare, 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 – Issue – Oxygen and Air inlet Fittings Were Reversed During Assembly

Recall Class: Class I

Recall Initiation Date: October 1, 2013

Products:

  • 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.

Affected Lot Numbers:

The affected products were manufactured from April 1, 2007 through October 31, 2013 and distributed from October 1, 2007 through October 31, 2013.

Use: These devices are used to resuscitate infants and newborns and regulate body temperature.

Recalling Firm:
GE Healthcare
9900 Innovation Drive
Wauwatosa, Wisconsin 53226

Reason for Recall: 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.

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

FDA District: Baltimore District Office

FDA Comments:
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.

The safety issues described the:

  • Description and affected product details.
  • Safety instructions.
  • Photos showing the back of the resuscitation system where the Air and Oxygen fillings are located.
  • Appendix of the Affected Product Serial Number Definition and Configuration of Fittings.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 02/28/2014
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