# China NMPA Product Recall - Mobile X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/f6c0c04c-b4d9-4d51-ab4b-2c19e14090e1/
Source feed: China

> China NMPA product recall for Mobile X-ray machine by Philips (China) Investment Co., Ltd. published March 25, 2021. Recall level: Level 3. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its MobileDiagnost wD

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its mobile X-ray machines.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-03-25
- Product Name: Mobile X-ray machine
- Recall Level: Level 3
- Recall Reason: Some MobileDiagnostwDR 2.1 systems sold in China incorrectly use Class I laser emitters instead of Class II laser emitters. Although Class I lasers are widely used overseas, Class I laser emitters cannot be used in China due to registration and product parameter restrictions.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its MobileDiagnost wDR 2.1 portable X-ray machines in China, as reported by the National Medical Products Administration (NMPA) on March 25, 2021, with further publication by the Shanghai Municipal Drug Administration on May 9, 2021. The recall, documented internally as FCO71200202, addresses a critical compliance issue regarding the device's laser emitter. The core problem stems from the incorrect integration of a Class I laser emitter in these systems, contrary to the required Class II classification for products sold in China. While Class I lasers are acceptable internationally, their use in China presents significant registration and product parameter conflicts within the country's regulatory framework. This discrepancy rendered the product non-compliant with its approved registration certificate (No.: 国械注进20182300009), despite successful overseas usage. As a result, Philips (China) is undertaking this recall to rectify the regulatory non-conformity. Detailed information regarding the affected product models, specifications, and specific batches is available in the accompanying "Medical Device Recall Event Report Form." This action underscores the stringent regulatory requirements enforced by the NMPA for medical devices within China.

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