# China NMPA Product Recall - EPIQ7 Color Doppler Ultrasound Diagnostic System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-ultrasound-inc/695db5dc-7197-45a1-b44e-0237077f72c6/
Source feed: China

> China NMPA product recall for EPIQ7 Color Doppler Ultrasound Diagnostic System by Philips Ultrasound, Inc. published April 22, 2015. Recall level: . Philips (China) Investment Co., Ltd., in conjunction with its manufacturer Philips Ultrasound, Inc.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its EPIQ7 color ultrasound diagnostic system.
- Company Name: Philips Ultrasound, Inc.
- Publication Date: 2015-04-22
- Product Name: EPIQ7 Color Doppler Ultrasound Diagnostic System
- Recall Reason: When the EPIQ7 ultrasound system is set to "Metric" and weight and/or height are entered, incorrect unit conversion can lead to incorrect calculation of the patient's body surface area (BSA).
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Ultrasound, Inc.
- Summary: Philips (China) Investment Co., Ltd., in conjunction with its manufacturer Philips Ultrasound, Inc., initiated a voluntary global recall for its EPIQ7 Color Doppler Ultrasound Diagnostic System on April 22, 2015. This action stemmed from a identified software conversion error within the system. The critical issue manifests when the ultrasound system is set to "Metric" units, resulting in incorrect calculations of a patient's body surface area (BSA) upon the entry of weight and/or height data. While no patient injuries have been reported globally related to this defect, the potential for inaccurate diagnostic information based on erroneous BSA values prompted the recall. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), Philips has actively informed all affected users and implemented a formal Field Corrective Action (FCO). As part of this corrective measure, Philips' field service engineers are contacting impacted customers to schedule and perform essential software updates. This process aims to rectify the calculation error, ensuring the accurate determination of BSA and maintaining diagnostic reliability. The recall specifically affects 36 units imported into China.

Company: https://www.globalkeysolutions.net/companies/philips-ultrasound-inc/879d9f04-50c3-42b3-8196-4377eba021c1/