# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/1b667b82-fa07-4249-8a62-a932687b3cba/
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic System by Philips (China) Investment Co., Ltd. published May 07, 2019. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. has initiated a voluntary Class II recall for specific models o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its color ultrasound diagnostic systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-05-07
- Product Name: Color Doppler Ultrasound Diagnostic System
- Recall Level: Level 2 Recall
- Recall Reason: Philips discovered a software issue during internal testing of its EPIQ & Affiniti series ultrasound systems with software versions 1.9 or 2.1 that could accidentally move one patient's image to another patient's folder when the user uses the editing function on the Patient Data Input (PDE) screen.
- 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 for specific models of its color Doppler ultrasound diagnostic systems. The recall, published on May 7, 2019, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a critical software issue identified during internal product testing. The defect affects EPIQ and Affiniti series ultrasound systems running software versions 1.9 or 2.1. The primary concern is that when users employ the editing function on the Patient Data Input (PDE) screen, there is a possibility of inadvertently transferring a patient's image to a different patient's folder. This flaw poses a risk of incorrect patient data association, potentially leading to misdiagnosis or inappropriate treatment based on erroneous information. The company's required action is a comprehensive recall of the affected devices, detailed by specific registration certificate numbers. This proactive measure aims to mitigate potential patient safety risks associated with data integrity.

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