# China NMPA Product Recall - Positron emission tomography (PET) and X-ray computed tomography (models: Biograph mCTS, Biograph mCTX)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-medical-solutions-usa-inc/1a04c137-1b72-483b-8dbd-51bc9ba19dc8/
Source feed: China

> China NMPA product recall for Positron emission tomography (PET) and X-ray computed tomography (models: Biograph mCTS, Biograph mCTX) by Siemens Medical Solutions USA, Inc. published March 01, 2017. Recall level: Level II. Siemens Healthineers initiated a voluntary Class II recall of its Positron Emission Tomography and X

---

## 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: 2017-03-01
- Product Name: Positron emission tomography (PET) and X-ray computed tomography (models: Biograph mCTS, Biograph mCTX)
- Recall Level: Level II
- Recall Reason: The laser positioning light window, used for laser positioning and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system, may become loose or detached. This could result in personnel coming into contact with electrical or rotating parts of the rack, causing serious injury such as electric shock or physical harm.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Medical Solutions USA, Inc.
- Summary: Siemens Healthineers initiated a voluntary Class II recall of its Positron Emission Tomography and X-ray Computed Tomography Systems, specifically Biograph mCTS and Biograph mCTX models. This recall, published by the National Medical Products Administration (NMPA) on March 1, 2017, with an initial report date of December 15, 2016, addresses a critical safety concern. The main issue identified is that the laser positioning light window, integrated into the front cover of these medical imaging systems, may become loose or detach. This detachment poses a significant risk, as it could allow personnel to inadvertently contact internal electrical or rotating components, potentially leading to serious injuries such as electric shock or physical harm. Under the NMPA's regulatory framework, the company's required actions involve issuing a customer notification letter (MI516/16/S) to inform users of the identified risk and preventive measures. Furthermore, customers are explicitly instructed that if a laser positioning light window is found to be missing or loose, they must immediately cease using the Biograph mCT or Biograph mCT Flow system and contact their local Siemens customer service engineer for corrective action. The recall impacts 31 units sold in various regions, including China.

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