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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/4b9eb8db-b1c1-435e-b640-e7a3f8e7e5d5/
Source feed: China

> China NMPA product recall for Medical diagnostic X-ray system by Philips (China) Investment Co., Ltd. published August 17, 2021. Recall level: Level 3 Recall. On August 17, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of i

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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: 2021-08-17
- Product Name: Medical diagnostic X-ray system
- Recall Level: Level 3 Recall
- Recall Reason: The affected products are due to a software issue that Philips is aware of: directly changing the position of the collimator ray baffle after a lock command will cause changes in kV and mA values. This software issue leads to overexposure or underexposure of the image.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On August 17, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its medical diagnostic X-ray systems, under the oversight of the National Medical Products Administration (NMPA). The recall stems from an identified software anomaly within the affected products. This critical issue occurs when the position of the collimator beam baffle is adjusted immediately following a lock command, which can inadvertently alter the kilovoltage (kV) and milliampere (mA) values. Such alterations pose a significant risk, potentially causing either overexposure or underexposure in diagnostic images. This malfunction could compromise the quality and diagnostic utility of medical images, potentially impacting patient care. Philips (China) has documented this issue internally as FCO 70900051. As part of this corrective action, the company has advised referring to the "Medical Device Recall Event Report Form" for specific details on the models, specifications, and batches of the impacted X-ray systems, ensuring affected units are identified and addressed promptly.

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