# China NMPA Product Recall - Medical diagnostic X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/c977fd2f-ef33-4b5b-a297-1eb4daa92d29/
Source feed: China

> China NMPA product recall for Medical diagnostic X-ray system by Philips (China) Investment Co., Ltd. published January 06, 2020. Recall level: Level 2. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its medical diagnostic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls medical diagnostic X-ray systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-01-06
- Product Name: Medical diagnostic X-ray system
- Recall Level: Level 2
- Recall Reason: The CombiDiagnost R90 GCF/PCF system has issues that could pose risks to patients or users, including an Error 80 issue causing the examination bed to lock, and the SPDU thermal switch potentially being installed incorrectly and malfunctioning.
- 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 medical diagnostic X-ray systems, as reported by the National Medical Products Administration (NMPA) on January 6, 2020. This action addresses two significant technical issues that could impact patient or user safety. The first, termed "Error 80," involves a malfunction in the examination bed's tilt and vertical movement, causing it to lock in position and necessitating professional intervention. The second issue concerns the System Power Distribution Unit (SPDU), where thermal switches, crucial for preventing overheating in the main power supply, may be incorrectly installed and prone to malfunction. While these problems were identified through internal monitoring and complaints, Philips confirmed that no related patient injuries have been reported globally. The recall, overseen by regulatory bodies like the NMPA and Shanghai Municipal Drug Administration, requires Philips to retrieve affected products (Registration Certificate No.: 20182300210). Specific details regarding affected models and batches are available in the accompanying Medical Device Recall Event Report Form, ensuring corrective action for potentially impacted devices.

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