# China NMPA Product Recall - MobileDiagnost WDR (Mobile Digital Medical X-ray Imaging System)

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/17666674-0f87-4926-996f-30f0ce3fa171/
Source feed: China

> China NMPA product recall for MobileDiagnost WDR (Mobile Digital Medical X-ray Imaging System) by Philips Healthcare (Suzhou) Co., Ltd. published October 26, 2020. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. has initiated a voluntary Level 3 recall for its Mobile Digita

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. has initiated a voluntary recall of its mobile digital medical X-ray imaging system.
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2020-10-26
- Product Name: MobileDiagnost WDR (Mobile Digital Medical X-ray Imaging System)
- Recall Level: Level 3 Recall
- Recall Reason: Philips internal testing revealed that its MobileDiagnost wDR mobile digital medical X-ray imaging system lacked a Class 2 Chinese laser instruction label. According to GB7247.1-2012, a Chinese instruction label should also be affixed.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. has initiated a voluntary Level 3 recall for its Mobile Digital Medical X-ray Imaging System (model: MobileDiagnost wDR) due to the absence of a required Class 2 Chinese laser instruction label. The company identified this issue during internal testing, reporting it on September 14, 2020, with the National Medical Products Administration (NMPA) publishing the recall on October 26, 2020. The primary issue stems from non-compliance with the Chinese national standard GB7247.1-2012, which mandates the affixing of such labels on medical devices. While no injuries have been reported, this regulatory framework ensures products meet national safety and information standards. As corrective actions, Philips has notified affected customers. Field engineers will conduct on-site updates to affix the missing Chinese laser instruction labels to all 22 affected MobileDiagnost wDR units sold in China, ensuring full compliance.

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-suzhou-co-ltd/f697ee6b-76f7-4128-9e8c-71e7ebe08572/