# China NMPA Product Recall - X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/7c175d41-be6f-4a1a-8390-e86e7919a581/
Source feed: China

> China NMPA product recall for X-ray machine by Philips (China) Investment Co., Ltd. published May 14, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its X-ray machines on 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls X-ray machines.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-05-14
- Product Name: X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: The issue stems from the thermal switch in the three-phase transformer within the system's SPDU (System Power Distribution Unit) potentially being installed incorrectly, causing the equipment to malfunction.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its X-ray machines on May 14, 2020. This action, reported by the Shanghai Municipal Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a potential critical safety concern. The core issue identified is the possible incorrect installation of a thermal switch within the three-phase transformer, specifically located in the System Power Distribution Unit (SPDU) of the affected X-ray systems. This installation error could lead to equipment malfunction, posing risks to patient safety and operational reliability. The recall pertains to X-ray machines bearing Registration Certificate No. 国械注进20192060236. Philips (China) Investment Co., Ltd. is taking proactive steps to manage this deviation from quality standards, ensuring compliance with regulatory frameworks governing medical devices in China. Detailed information regarding specific product models, specifications, and affected batches is made available through a "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for further guidance on the required actions to address the recalled units. The company's immediate action aims to mitigate potential risks associated with the identified manufacturing defect.

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