# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/91f0115a-a862-4a29-ab4b-2ff09984fc8b/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips (China) Investment Co., Ltd. published June 19, 2017. Recall level: Level 3. On June 19, 2017, the National Medical Products Administration (NMPA) published details of a volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls digital medical X-ray imaging systems
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3
- Recall Reason: The product in question is malfunctioning and cannot correctly acquire X-ray images.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On June 19, 2017, the National Medical Products Administration (NMPA) published details of a voluntary recall initiated by Philips (China) Investment Co., Ltd. This recall addresses specific digital medical X-ray imaging systems, identified by Registration Nos. 国械注20152301232 and 国械注进20152301233. The critical issue prompting this action is a malfunction within the affected devices, which renders them unable to correctly acquire X-ray images. This malfunction could potentially compromise diagnostic accuracy and patient care. While no specific inspection dates were provided in this recall notice, the company's decision to conduct a voluntary recall indicates their recognition of a product deficiency. The recall is classified as Class III, typically implying that the use of or exposure to the product is not likely to cause adverse health consequences. Under the regulatory framework of China's NMPA, Philips (China) Investment Co., Ltd. is responsible for retrieving the affected digital medical X-ray imaging systems from the market. Further detailed information concerning the specific models, specifications, and batch numbers of the recalled products is available in the 'Medical Device Recall Event Report Form' provided with the NMPA's announcement. This action ensures the removal of potentially malfunctioning equipment, thereby upholding the integrity of medical imaging practices.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/