China NMPA Product Recall - Baby radiant warmer

Ohmeda Medical, a Division of Datex-Ohmeda Inc., in collaboration with its Chinese distributor, GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., initiated a voluntary recall of Infant Radiant Warmers (models Giraffe and Panda) on March 3, 2014. This action was taken under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration. The primary issue identified was a manufacturing defect where the oxygen and air wall or tank inlet connectors on the back panel of the warming table were reversed during assembly. This critical error could lead to an incorrect air/oxygen concentration delivered to infants and pediatric patients, making the mixer knob settings on integrated resuscitation devices inaccurate and potentially compromising patient safety. The recall specifically impacts 223 units sold in China, with the issue also affecting products distributed in the United States, Australia, and Canada. To address this, GE Healthcare has outlined several corrective actions. These include promptly notifying customers about the potential safety hazard, dispatching GE engineers to conduct on-site inspections of the connectors and verify mixer accuracy, and providing free-of-charge corrections for all identified affected devices.