# China NMPA Product Recall - Ultrasound diagnostic system

Source: https://www.globalkeysolutions.net/records/china_product_recall/yum-brands-inc-esaote-spa/0199f5b4-fcec-4ec4-98ac-523a912b7795/
Source feed: China

> China NMPA product recall for Ultrasound diagnostic system by Yum! Brands Inc. (ESAOTE S.P.A.) published November 16, 2018. Recall level: Level 3. ESAOTE S.p.A., supported by its agent ESAOTE (Shenzhen) Medical Equipment Co., Ltd., initiated a Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Esaote S.p.A., Inc. is voluntarily recalling its ultrasound diagnostic systems.
- Company Name: Yum! Brands Inc. (ESAOTE S.P.A.)
- Publication Date: 2018-11-16
- Product Name: Ultrasound diagnostic system
- Recall Level: Level 3
- Recall Reason: Due to a software error, the default settings are incorrect when the PW mode of the PA023E and PA023(E) probes is enabled, which may cause the probes to overheat.
- Discovering Company: Baisheng (Shenzhen) Medical Equipment Co., Ltd.
- Manufacturing Company: Yum! Brands Inc. (ESAOTE S.P.A.)
- Summary: ESAOTE S.p.A., supported by its agent ESAOTE (Shenzhen) Medical Equipment Co., Ltd., initiated a Class III voluntary recall of several ultrasound diagnostic systems, as published by the National Medical Products Administration (NMPA) on November 16, 2018. The recall stems from a software defect that causes incorrect default settings when the Pulse Wave (PW) mode is enabled for specific probes, namely PA023E and PA023(E). This flaw carries the risk of causing the probes to overheat during clinical ultrasound diagnostic examinations. The recall impacts multiple models, including MyLab 60, MyLab 90, MyLab Class C, MyLabTwice, and MyLabTwice eHD, identified by various national medical device registration certificates. Affected regions are extensive, spanning countries such as Italy, Brazil, USA, Hong Kong, France, Mexico, Austria, Saudi Arabia, India, Spain, and China. To address this safety concern, ESAOTE's required corrective actions involve developing and releasing a defect repair software, which will then be installed on all affected customer devices to mitigate the overheating risk and ensure the safe operation of its ultrasound diagnostic systems.

Company: https://www.globalkeysolutions.net/companies/yum-brands-inc-esaote-spa/2ea88090-de90-4e9f-bc55-05d55702b4bc/