# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/6223059c-51e5-4eec-b4b7-543048f58416/
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic System by Philips (China) Investment Co., Ltd. published August 10, 2021. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall of multiple models of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling color ultrasound diagnostic systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-08-10
- Product Name: Color Doppler Ultrasound Diagnostic System
- Recall Level: Level 2 Recall
- Recall Reason: The rotating arm locking device on some EPIQ ultrasound system control panels may malfunction, preventing it from locking properly. If the rotating arm locking device fails to lock, the control panel and display may rotate freely when the user adjusts the display position or during transport/movement of the machine.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall of multiple models of its color Doppler ultrasound diagnostic systems, as reported by the National Medical Products Administration (NMPA) on August 10, 2021. The company identified a critical issue where the rotating arm locking device on the control panels of some EPIQ ultrasound systems may malfunction. This defect prevents the device from locking properly, leading to the control panel and monitor potentially rotating freely during user adjustments or machine transport. This presents a potential operational and safety risk in clinical environments. This action falls under the regulatory oversight of the NMPA, which designates it as a Class II recall, indicating a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Affected products are identified by specific registration certificate numbers, such as 国械注进20203060200, 国械注进20203060322, and others. As part of the required actions, Philips has released a "Medical Device Recall Event Report Form" that provides comprehensive details on the specific models, specifications, and batches impacted by this recall, guiding customers on the necessary steps to mitigate the identified risk.

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