# China NMPA Product Recall - Heat exchange water tank system, variable temperature water tank system

Source: https://www.globalkeysolutions.net/records/china_product_recall/linova-china-medical-technology-co-ltd/66b60fe4-de54-4c00-ac9a-99a744eda507/
Source feed: China

> China NMPA product recall for Heat exchange water tank system, variable temperature water tank system by Linova (China) Medical Technology Co., Ltd. published April 08, 2019. Recall level: Level 2 Recall. Linofa (China) Medical Technology Co., Ltd. initiated a voluntary Class II recall of its heat exchan

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Linopa (China) Medical Technology Co., Ltd. is voluntarily recalling its heat exchange water tank systems, variable temperature water tank systems, and heat exchange water tank systems.
- Company Name: Linova (China) Medical Technology Co., Ltd.
- Publication Date: 2019-04-08
- Product Name: Heat exchange water tank system, variable temperature water tank system
- Recall Level: Level 2 Recall
- Recall Reason: Problems such as evaporator coil corrosion, switching valve malfunction or performance issues, exhaust valve leakage, and drain valve leakage.
- Discovering Company: Linova (China) Medical Technology Co., Ltd.
- Manufacturing Company: Linova (China) Medical Technology Co., Ltd.
- Summary: Linofa (China) Medical Technology Co., Ltd. initiated a voluntary Class II recall of its heat exchange and variable temperature water tank systems. This action, reported by the National Medical Products Administration (NMPA) on April 8, 2019, addresses significant product defects compromising device performance and safety. The identified issues include evaporator coil corrosion, malfunction or performance problems with switching valves, and leakage from both exhaust and drain valves. These critical component failures necessitated the recall of various products, identified by specific registration certificate numbers such as 国械注进20172452137. The regulatory framework for this action involves the NMPA and the Shanghai Food and Drug Administration, under whose oversight these devices were registered. The required action by Linofa is a comprehensive recall to mitigate risks associated with the defective medical devices, ensuring product quality and patient safety standards are maintained.

Company: https://www.globalkeysolutions.net/companies/linova-china-medical-technology-co-ltd/490c341f-7e65-4a7c-aeed-305db797fc61/