# China NMPA Product Recall - High-intensity focused ultrasound tumor treatment system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-xindi-industrial-co-ltd/b3e2e60c-4e40-4ca9-9971-e39ef552f948/
Source feed: China

> China NMPA product recall for High-intensity focused ultrasound tumor treatment system by Shanghai Xindi Industrial Co., Ltd. published September 29, 2021. Recall level: Level 3 Recall. Shanghai Xindi Industrial Co., Ltd. has initiated a voluntary Level III recall of its High-Intensity

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Xindi Industrial Co., Ltd. has initiated a voluntary recall of its high-intensity focused ultrasound (HIFU) tumor treatment system.
- Company Name: Shanghai Xindi Industrial Co., Ltd.
- Publication Date: 2021-09-29
- Product Name: High-intensity focused ultrasound tumor treatment system
- Recall Level: Level 3 Recall
- Recall Reason: Nine pieces of equipment were mistakenly pre-installed with control software of incorrect version numbers at the factory, and the software version numbers were not labeled in accordance with software version numbering standards.
- Discovering Company: Shanghai Xindi Industrial Co., Ltd.
- Manufacturing Company: Shanghai Xindi Industrial Co., Ltd.
- Summary: Shanghai Xindi Industrial Co., Ltd. has initiated a voluntary Level III recall of its High-Intensity Focused Ultrasound Tumor Treatment System. This action, reported on September 29, 2021, falls under the regulatory oversight of the National Medical Products Administration (NMPA). The primary issue identified was a manufacturing defect affecting nine devices: incorrect installation of control software with non-conforming version numbers. Specifically, the operating software version did not meet the technical requirements, which mandate control software versions to be 2.4 build 1, 2.4.0.1, or 3.0.0.0. The company is required to recall the affected products to address these critical software discrepancies. This voluntary recall demonstrates the company's commitment to product quality and compliance with the NMPA's medical device regulations, ensuring the safety and intended performance of their devices. Detailed information on the specific models, specifications, and batches involved is available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/shanghai-xindi-industrial-co-ltd/31d45901-5a0b-4678-9fc8-8a4736d01573/