# China NMPA Product Recall - Phototherapy equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/548e14e3-b6f9-4324-a55a-79e3413b5adf/
Source feed: China

> China NMPA product recall for Phototherapy equipment by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published February 26, 2020. Recall level: Level 2 Recall. On February 26, 2020, the National Medical Products Administration (NMPA) reported that GE Healthcar

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. has initiated a voluntary recall of phototherapy equipment.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2020-02-26
- Product Name: Phototherapy equipment
- Recall Level: Level 2 Recall
- Recall Reason: Some batches of phototherapy devices may have an output light intensity lower than the recommended minimum. This issue is related to the light guide being exposed to high temperatures, which is explicitly prohibited in the instruction manual.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/