# China NMPA Product Recall - Infrared ear thermometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/koo-medical-equipment-shanghai-co-ltd/9736374d-7b12-4a81-b997-6eb401a63660/
Source feed: China

> China NMPA product recall for Infrared ear thermometer by Koo Medical Equipment (Shanghai) Co., Ltd. published October 27, 2021. Recall level: Level 3 Recall. Yilong Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its PRO6000

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yilong Medical Equipment (Shanghai) Co., Ltd. has initiated a voluntary recall of infrared ear thermometers.
- Company Name: Koo Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2021-10-27
- Product Name: Infrared ear thermometer
- Recall Level: Level 3 Recall
- Recall Reason: Infrared ear thermometer PRO6000 probe tip overheating
- Discovering Company: Yilong Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Koo Medical Equipment (Shanghai) Co., Ltd.
- Summary: Yilong Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its PRO6000 infrared ear thermometers on October 27, 2021. This action stemmed from global feedback concerning a critical safety issue: the overheating of the product's probe tip. The recall affects specific models, specifications, and batches, with comprehensive details provided in the "Medical Device Recall Event Report Form." The regulatory oversight for this action falls under the National Medical Products Administration (NMPA) and was reported through the Shanghai Municipal Drug Administration, ensuring adherence to established medical device safety standards in China. The required action by the company is the voluntary recall of its infrared ear thermometers, identified by Registration Certificate No.: 国械注进20192070072. This proactive measure underscores the company's commitment to patient safety and compliance with product quality regulations. Consumers and healthcare professionals are advised to consult the official recall documentation for complete instructions regarding the affected devices.

Company: https://www.globalkeysolutions.net/companies/koo-medical-equipment-shanghai-co-ltd/629448d1-2f5c-4db0-8ac4-522b6d76800f/