China NMPA Product Recall - Infant incubator, multi-functional incubator, phototherapy equipment (trade name: Giraffe), baby warmer, baby radiant warmer
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On January 19, 2017, the National Medical Products Administration (NMPA) published a recall notice regarding several medical devices manufactured by Ohmeda Medical. GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. served as the responsible agent in China. The affected products included various models of infant incubators, multifunctional incubators, phototherapy equipment (Giraffe), infant warmers, and baby radiant warmers. The recall was initiated due to a potential safety issue involving specific US-style "Taller Bridge" power cords, manufactured by Electri-Cord, which could overheat. This defect posed a risk of fire, burning, smoke, or sparks at the power cord's connection point, potentially causing heat injuries. While the risk was significant, no injuries were reported. Ohmeda Medical voluntarily recalled these products, with the issue first identified around December 2016. Importantly, the problematic batches were confirmed not to have been sold or imported into China. Consequently, the required action for stakeholders in China was to contact GE Healthcare for any inquiries. Additionally, the NMPA requested that provincial, autonomous region, and municipal food and drug administrations enhance their oversight and management of such products.
- Company
- Ohmeda Medical
ID · d3ed55fb-a6f8-4e8e-96f8-f2bc8387ee6e