# China NMPA Product Recall - Electrophysiological recording system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-information-technologies/389b9bb6-3482-4815-b752-5d9ea509ce3a/
Source feed: China

> China NMPA product recall for Electrophysiological recording system by GE Medical Systems Information Technologies published June 17, 2016. Recall level: . GE Healthcare Trading Development (Shanghai) Co., Ltd., operating under the regulatory framework of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare recalls electrophysiological recording systems and other products.
- Company Name: GE Medical Systems Information Technologies
- Publication Date: 2016-06-17
- Product Name: Electrophysiological recording system
- Recall Reason: GE Healthcare recently discovered that certain checks were missed during maintenance in India, necessitating a re-maintenance of these products.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems Information Technologies
- Summary: GE Healthcare Trading Development (Shanghai) Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA), issued a voluntary recall for specific electrophysiological recording and hemodynamic monitoring systems. The affected products, manufactured by GE Medical Systems, include models like Cardiolab EP 2000, EP 4000, EP 7000, Mac-Lab, ComboLab, and Cardiolab II Plus amplifier systems. The primary reason for this action was the omission of certain critical checks during maintenance procedures in India. Importantly, the company confirmed that none of the recalled devices were sold in China; the recall's scope is exclusively limited to units distributed in India, and no injuries have been reported. The required action involves a comprehensive re-maintenance for all identified affected products in India to rectify the missed checks. The NMPA, in its oversight capacity, urged local food and drug administrations to reinforce supervision of similar medical devices.

Company: https://www.globalkeysolutions.net/companies/ge-medical-systems-information-technologies/4f9305a8-d284-4eb1-bdd2-f15eede2ad53/