China NMPA Product Recall - Phototherapy equipment

On February 26, 2020, the National Medical Products Administration (NMPA) reported that GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of certain phototherapy equipment. This action, also publicized by the Shanghai Municipal Drug Administration on April 1, 2020, addresses a critical product performance issue. The company discovered that some batches of their phototherapy devices exhibited an output light intensity potentially below the recommended minimum level. Investigation revealed that this deficiency was attributed to the light guide being exposed to high temperatures, a condition explicitly forbidden in the equipment's operational instructions. As a result, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is recalling its phototherapy equipment (Registration Certificate No.: CFDA (Imported) 2014 No. 2262775) to mitigate potential risks associated with suboptimal light therapy. The recall ensures adherence to product specifications and patient safety standards under the NMPA's regulatory oversight.