# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/2fd68526-f7d8-4290-b29c-d56e795f2e01/
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Siemens Healthcare Diagnostics Inc. published December 07, 2016. Recall level: Class III Recall. The National Medical Products Administration (NMPA) reported on December 7, 2016, that Siemens Medic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated sample handling system.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2016-12-07
- Product Name: Fully automated sample processing system
- Recall Level: Class III Recall
- Recall Reason: The plugs connected to the power cord of the automation system may overheat, potentially causing an electrical hazard.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: The National Medical Products Administration (NMPA) reported on December 7, 2016, that Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., representing Siemens Healthcare Diagnostics Inc., initiated a voluntary Level III recall of its Fully Automated Sample Processing Systems. This action followed a report dated October 12, 2016. The core issue identified was a potential electrical hazard: the power cord plug connected to the automation system's internal power supply, specifically for the refrigeration and centrifuge modules, was found to potentially overheat. This defect affects products, including specific Cold Storage and Centrifuge Modules, that were shipped since May 21, 2014, or after May 2014. The supplier had informed Siemens about the problem with certain power cable configurations.

In response, Siemens outlined two key corrective measures. Firstly, the company committed to immediately notifying all affected customers through an official customer letter. Secondly, Siemens' customer service engineers are responsible for replacing the faulty power cables in all identified units. This recall highlights the NMPA's role in overseeing medical device safety, ensuring manufacturers address potential risks and maintain product integrity across products installed and sold within China, thereby mitigating the identified electrical hazard.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/