# China NMPA Product Recall - Computed Tomography X-ray Imaging Reader System

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-fujifilm-imaging-equipment-co-ltd/731593f0-e2c6-4193-aac2-d51e6e3b6134/
Source feed: China

> China NMPA product recall for Computed Tomography X-ray Imaging Reader System by Suzhou Fujifilm Imaging Equipment Co., Ltd. published January 12, 2017. Recall level: Level 3 Recall. Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall of its Computed T

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou Fujifilm Imaging Equipment Co., Ltd. is voluntarily recalling its computed tomography (CT) X-ray imaging reader system.
- Company Name: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Publication Date: 2017-01-12
- Product Name: Computed Tomography X-ray Imaging Reader System
- Recall Level: Level 3 Recall
- Recall Reason: The DQE value (quantum detection efficiency, i.e., image quality) deviates from the registered specification.
- Discovering Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Manufacturing Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Summary: Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall of its Computed Tomography (CT) X-ray Imaging Reader Systems in mainland China, as reported on January 10, 2017, and subsequently published by the National Medical Products Administration (NMPA) on January 12, 2017. The primary concern involved the product's Quantum Detection Efficiency (DQE), which indicates image quality. The DQE value was found to deviate from the company's registered specifications for the Chinese market, even though it met Fujifilm's unified global sales specifications. No patient injuries have been reported related to this issue. The recall affects four units across FCR CAPSULA XLII and FCR CAPSULA X models. As part of the required actions, three unsold units from a warehouse will be returned to the factory for repair and re-inspection. Additionally, one unit that had been installed in a hospital will be isolated and disposed of. This recall underscores the importance of adhering to specific local regulatory registration standards.

Company: https://www.globalkeysolutions.net/companies/suzhou-fujifilm-imaging-equipment-co-ltd/05879a2b-0ed5-4e2a-be94-59a6db3bddf7/