# China NMPA Product Recall - X-ray computed tomography device

Source: https://www.globalkeysolutions.net/records/china_product_recall/neusoft-medical-systems-co-ltd/5e97167b-8fd3-4506-a568-573eceaff2fc/
Source feed: China

> China NMPA product recall for X-ray computed tomography device by Neusoft Medical Systems Co., Ltd. published January 29, 2019. Recall level: Level 3 Recall. Shenyang Neusoft Medical Systems Co., Ltd. initiated a Class III voluntary recall for one unit of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Neusoft Medical Systems Co., Ltd. in Shenyang is voluntarily recalling its X-ray computed tomography (CT) equipment.
- Company Name: Neusoft Medical Systems Co., Ltd.
- Publication Date: 2019-01-29
- Product Name: X-ray computed tomography device
- Recall Level: Level 3 Recall
- Recall Reason: This voluntary recall is only to correct printing errors on the label and main control panel label of one NeuViz Dual (1.) X-ray computed tomography unit. It is unrelated to the performance, quality, or use of the CT unit and its accessories. The performance of the product in question meets the registered product standards.
- Discovering Company: Shenyang Neusoft Medical Systems Co., Ltd.
- Manufacturing Company: Neusoft Medical Systems Co., Ltd.
- Summary: Shenyang Neusoft Medical Systems Co., Ltd. initiated a Class III voluntary recall for one unit of its NeuViz Dual (1) X-ray Computed Tomography device (model NDLCN160003), as reported to the National Medical Products Administration (NMPA) on January 23, 2019, with the recall notice published on January 29, 2019. The recall stems from minor printing errors identified on both the whole machine label and the main control panel label of the affected device. The company clarified that these labeling discrepancies are purely administrative and have no impact on the performance, quality, or safe operation of the CT unit or its accessories, confirming the product continues to meet all registered standards. As part of the corrective actions, Shenyang Neusoft Medical Systems Co., Ltd. is issuing a formal 'Recall Notice' to the user of the affected unit. Furthermore, a service engineer will be dispatched to the site to physically replace the erroneous labels. Importantly, this recall does not necessitate the return or recycling of the product, and the equipment remains fully functional for normal use.

Company: https://www.globalkeysolutions.net/companies/neusoft-medical-systems-co-ltd/57ea37ca-5a5e-45e4-b66a-6abaa6cb3abd/