China NMPA Product Recall - Infant incubator, multi-functional incubator, phototherapy equipment (trade name: Giraffe), baby warmer, baby radiant warmer
Discuss this record with AI
On February 3, 2017, Ohmeda Medical initiated a voluntary recall concerning several infant medical devices, distributed by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. The affected products include various Infant Incubators, Multifunctional Incubators, Phototherapy equipment (specifically "Giraffe"), baby warmers, and baby radiant warmers. The critical safety issue identified was overheating power cords, which could lead to severe consequences such as fires, burning, smoke, or sparks at the power cord's connection to the wall socket, potentially causing significant heat damage. While the manufacturer, Ohmeda Medical, stated these particular recalled products were not sold in China, the regulatory framework involved the former China Food and Drug Administration (CFDA), now the National Medical Products Administration (NMPA), as evidenced by the CFDA import medical device registration certificates. In response to this safety concern, provincial, autonomous region, and municipal food and drug administrations were directed to strengthen their supervision and management of similar medical devices to ensure public safety.
- Company
- Ohmeda Medical
ID · 36d5ccb5-333a-4912-b2f5-9df8e2fdc228