# China NMPA Product Recall - Whole-body X-ray computed tomography system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/e236096a-bdee-48d1-865b-d99c27b2433a/
Source feed: China

> China NMPA product recall for Whole-body X-ray computed tomography system by GE Healthcare (China) Co., Ltd. published December 15, 2015. Recall level: Level II. GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling its whole-body X-ray computed tomography (CT) system.
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2015-12-15
- Product Name: Whole-body X-ray computed tomography system
- Recall Level: Level II
- Recall Reason: During routine head scans, pathological artifacts may appear between brain tissue and the skull in skull images.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Whole-Body X-ray Computed Tomography Systems. This action, published on December 15, 2015, was prompted by customer complaints reporting the appearance of "pathological artifacts" in skull images during routine head scans. These artifacts were observed specifically between brain tissue and the skull, potentially affecting diagnostic accuracy. The company decided to recall the affected products to address these performance concerns. This recall falls under the regulatory oversight of the National Medical Products Administration (NMPA). While specific inspection dates are not provided, the recall itself serves as a corrective action in response to product performance issues identified through customer feedback. GE Healthcare is required to provide detailed information on the specific models, specifications, and batches of the affected devices in an attached "Medical Device Recall Event Report Form" to facilitate the recall process. The objective is to ensure the reliability and safety of medical imaging equipment for accurate patient diagnosis.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/