# China NMPA Product Recall - Medical diagnostic X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-ge-healthcare-co-ltd/0fe8ccbc-f2f4-4832-ae69-568ce6ca901f/
Source feed: China

> China NMPA product recall for Medical diagnostic X-ray system by Beijing GE Healthcare Co., Ltd. published September 14, 2016. Recall level: Level 2 Recall. Beijing GE Healthcare Medical Equipment Co., Ltd. initiated a voluntary Class II recall for specific

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing GE Healthcare Co., Ltd. voluntarily recalls medical diagnostic X-ray systems.
- Company Name: Beijing GE Healthcare Co., Ltd.
- Publication Date: 2016-09-14
- Product Name: Medical diagnostic X-ray system
- Recall Level: Level 2 Recall
- Recall Reason: GE Healthcare recently discovered a potential risk of horizontal X-ray tube arm sagging in certain batches of its XR 6000 products.
- Discovering Company: Beijing GE Healthcare Co., Ltd.
- Manufacturing Company: Beijing GE Healthcare Co., Ltd.
- Summary: Beijing GE Healthcare Medical Equipment Co., Ltd. initiated a voluntary Class II recall for specific batches of its medical diagnostic X-ray systems, particularly the XR 6000 product line. This recall, announced on September 14, 2016, and overseen by the National Medical Products Administration (NMPA) of China, was prompted by the company's recent discovery of a potential safety risk. The primary concern involves the horizontal X-ray tube arm, which has been identified with a risk of sagging during operation. Such a malfunction could compromise the precision and safety of diagnostic procedures, potentially impacting patient safety and the reliability of medical imaging. Operating within the stringent regulatory framework set by the NMPA, Beijing GE Healthcare took proactive measures to address this critical issue. The company voluntarily commenced the recall, underscoring its commitment to product quality and patient welfare. While no specific inspection dates are mentioned, the recall notification serves as a regulatory action to mitigate potential harm. Required actions involve identifying and retrieving affected units, with further detailed information regarding specific product models and serial numbers provided in the "Medical Device Recall Event Report Form." This swift and voluntary action ensures compliance with NMPA medical device regulations and aims to prevent any adverse events associated with the identified flaw.

Company: https://www.globalkeysolutions.net/companies/beijing-ge-healthcare-co-ltd/81b8f648-b549-4e0a-ae4e-0bdf363fe37e/