# China NMPA Product Recall - EPIQ5 Color Doppler Ultrasound Diagnostic System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-ultrasound-inc/77179a97-75a8-494c-b871-e5cc26301eed/
Source feed: China

> China NMPA product recall for EPIQ5 Color Doppler Ultrasound Diagnostic System by Philips Ultrasound, Inc. published April 22, 2015. Recall level: . Philips (China) Investment Co., Ltd., on behalf of its manufacturer Philips Ultrasound, Inc., initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its EPIQ5 color ultrasound diagnostic system.
- Company Name: Philips Ultrasound, Inc.
- Publication Date: 2015-04-22
- Product Name: EPIQ5 Color Doppler Ultrasound Diagnostic System
- Recall Reason: When the EPIQ5 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., on behalf of its manufacturer Philips Ultrasound, Inc., initiated a voluntary recall of its EPIQ5 Color Doppler Ultrasound Diagnostic System on April 22, 2015. The recall, overseen by the National Medical Products Administration (NMPA) in China, was prompted by a critical software conversion error. This flaw leads to an incorrect calculation of the patient's body surface area (BSA) when the system is set to metric units and specific weight or height data is entered. The issue affects a global scope, with 34 units imported to China identified by various batch numbers. While no adverse events have been reported worldwide to date, Philips has taken proactive measures. The company is actively notifying all affected users and has issued Field Corrective Actions (FCOs). Philips field service engineers are tasked with contacting customers to arrange and implement the necessary software updates to rectify the calculation error.

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