# China NMPA Product Recall - Medical jet cushion

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-zhenhai-medical-equipment-co-ltd/ccee7c3d-64ea-4380-9b29-fb4ca7dd0af7/
Source feed: China

> China NMPA product recall for Medical jet cushion by Shanghai Zhenhai Medical Equipment Co., Ltd. published March 05, 2021. Recall level: Level 3 Recall. Shanghai Sanhe Medical Device Co., Ltd. initiated a voluntary Class III recall for its medical air-j

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Sanhe Medical Devices Co., Ltd. is voluntarily recalling its medical air cushions.
- Company Name: Shanghai Zhenhai Medical Equipment Co., Ltd.
- Publication Date: 2021-03-05
- Product Name: Medical jet cushion
- Recall Level: Level 3 Recall
- Recall Reason: Due to the strong impact during transportation, some products in this batch may have experienced internal power connection wires becoming detached, resulting in a faulty fuse connection and rendering the product unusable.
- Discovering Company: Shanghai Sanhe Medical Equipment Co., Ltd.
- Manufacturing Company: Shanghai Zhenhai Medical Equipment Co., Ltd.
- Summary: Shanghai Sanhe Medical Device Co., Ltd. initiated a voluntary Class III recall for its medical air-jet cushions, as reported by the National Medical Products Administration (NMPA) on March 5, 2021, and by the Shanghai Municipal Drug Administration on April 1, 2021. The core issue driving this recall is the internal power connection wiring detachment, which occurred due to strong physical impacts during product transportation. This defect results in a poor fuse connection, rendering affected devices unable to power on and posing an operational reliability concern. The company proactively reported this malfunction for products associated with Registration Certificate No.: 沪械注准20172560596. This voluntary action adheres to the regulatory framework overseen by the NMPA, which mandates manufacturers address quality control deficiencies to ensure patient safety. A Class III recall signifies that exposure to the affected product is unlikely to cause adverse health consequences. Comprehensive details regarding the specific models, specifications, and batch numbers impacted by this recall are provided in the official "Medical Device Recall Report Form," guiding all relevant parties on appropriate follow-up actions.

Company: https://www.globalkeysolutions.net/companies/shanghai-zhenhai-medical-equipment-co-ltd/0dc9a345-3f06-49df-9e3a-6fbd1d5db534/