# China NMPA Product Recall - X-ray computed tomography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-llc/1c758448-7532-48e6-818b-4285fa78beb2/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by GE Medical Systems, LLC published November 23, 2020. Recall level: Level 2. GE Medical Systems, LLC initiated a voluntary Class II recall of specific X-ray computed tomography 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Medical Systems, LLC is voluntarily recalling X-ray computed tomography (CT) equipment.
- Company Name: GE Medical Systems, LLC
- Publication Date: 2020-11-23
- Product Name: X-ray computed tomography equipment
- Recall Level: Level 2
- Recall Reason: In rare cases, certain models and batches of products may exhibit a potential central black spot artifact on some Revolution Apex systems.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems, LLC
- Summary: GE Medical Systems, LLC initiated a voluntary Class II recall of specific X-ray computed tomography (CT) equipment, as reported by the National Medical Products Administration (NMPA) on November 23, 2020. The recall was prompted by the rare occurrence of potential central black spot pseudo-spots in some Revolution Apex systems. This issue could affect certain models and batches of products, specifically those covered by Registration Certificate No. 国械注进20203060334. GE Medical Systems Trade Development (Shanghai) Co., Ltd. officially reported this potential defect, leading to the recall. The required action involves the voluntary recall of the affected X-ray CT equipment to address the identified quality concern. Detailed information regarding the specific numbers, specifications, and batches of the recalled devices is contained within the "Medical Device Recall Event Report Form" provided as an attachment by the NMPA. This proactive measure by GE Medical Systems, LLC, under the oversight of the NMPA, aims to ensure patient safety and product quality by addressing the detected anomaly in the Revolution Apex CT systems.

Company: https://www.globalkeysolutions.net/companies/ge-medical-systems-llc/f2726879-5e5f-418f-9650-23534a1a0bd5/