# China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (CT) system

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-medical-solutions-usa-inc/685727a3-d55c-48af-a2c7-51404ff45536/
Source feed: China

> China NMPA product recall for Positron emission tomography (PET) and X-ray computed tomography (CT) system by Siemens Medical Solutions USA, Inc. published February 21, 2017. Recall level: Level II. Siemens Healthineers initiated a voluntary Class II recall for its Positron Emission Tomography and 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its positron emission tomography (PET) and X-ray computed tomography (CT) systems.
- Company Name: Siemens Medical Solutions USA, Inc.
- Publication Date: 2017-02-21
- Product Name: Positron emission tomography (PET) and X-ray computed tomography (CT) system
- Recall Level: Level II
- Recall Reason: The laser positioning light window may be loose or detached, which could cause people to touch the electrical or rotating parts of the frame when they put their hands through the window, resulting in electric shock or physical injury.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Medical Solutions USA, Inc.
- Summary: Siemens Healthineers initiated a voluntary Class II recall for its Positron Emission Tomography and X-ray Computed Tomography Systems, including Biograph mCTS, Biograph mCTX, and Biograph mCT Flow models. The company reported this issue to the National Medical Products Administration (NMPA) on December 15, 2016, with the NMPA publishing the recall on February 21, 2017. The primary concern stems from the laser positioning light window on the system's front cover, which may become loose or detached.

This defect poses a potential safety risk: users could inadvertently come into contact with internal electrical or rotating components of the system if the window is compromised, potentially leading to serious injuries such as electric shock or physical harm. While no user complaints had been reported, Siemens Healthineers identified this hazard.

In response, Siemens Healthineers, operating under NMPA's regulatory framework, is issuing customer notification letters (MI516/16/S) to inform users of the identified risk and preventive measures. Affected customers are instructed to immediately discontinue use of the equipment if they discover a missing or loose laser positioning light window and to contact their local Siemens customer service engineer for necessary repairs. The recall impacts 31 units sold in China and other global regions.

Company: https://www.globalkeysolutions.net/companies/siemens-medical-solutions-usa-inc/7a3f601f-1706-4c8c-9366-fcf8db169245/