China NMPA Product Recall - Infant incubator, multi-functional incubator, phototherapy equipment (trade name: Giraffe), baby warmer, baby radiant warmer

GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., acting on behalf of manufacturer Ohmeda Medical, initiated a voluntary medical device recall, publicized by the National Medical Products Administration (NMPA) on January 19, 2017. This recall, formally reported internally on December 21, 2016, addresses a significant safety concern involving several infant care products.

The recall targets various models, including Infant Incubators (Care Plus, Giraffe Incubator), Multifunctional Incubators (Giraffe), Phototherapy Equipment (Giraffe), Infant Warmers (Spot PT Lite series), and Baby Radiant Warmers (Panda). The primary issue identified is a potential safety hazard related to overheating US-style power cords, specifically "Taller Bridge" cords manufactured by Electri-Cord. This defect could lead to ignition, burning, smoke, or sparks at the connection point between the power cord and the wall outlet, posing a risk of heat injury. Fortunately, no injuries have been reported in connection with this issue.

Ohmeda Medical voluntarily recalled the affected products, which were stated as not intended for sale. Crucially for the Chinese market, it was confirmed that the affected product batches were not sold in China. Consequently, the primary action for China involved ensuring no sales occurred and directing inquiries to the recall contact person. The NMPA requested provincial, autonomous region, and municipal food and drug administrations to enhance supervision of similar products.