# China NMPA Product Recall - Positron emission tomography (PET) and computed tomography (CT) imaging systems, LightSpeed CT system, whole-body X-ray CT system, computed tomography imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-llc/ec568a7a-6a73-4f3b-b0fe-929f854d1fa6/
Source feed: China

> China NMPA product recall for Positron emission tomography (PET) and computed tomography (CT) imaging systems, LightSpeed CT system, whole-body X-ray CT system, computed tomography imaging system by GE Medical Systems, LLC published July 22, 2015. Recall level: . On July 22, 2015, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., in collaboration w

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. has voluntarily recalled the relevant imaging products.
- Company Name: GE Medical Systems, LLC
- Publication Date: 2015-07-22
- Product Name: Positron emission tomography (PET) and computed tomography (CT) imaging systems, LightSpeed CT system, whole-body X-ray CT system, computed tomography imaging system
- Recall Reason: GE Healthcare recently discovered that the specified installation torque value during the replacement of the power supply for the rotating part of the scanner cadaver was incorrect. Because of this error, the three mounting bolts securing the power supply may be overloaded during replacement. In extreme cases, these bolts could loosen as the cadaver rotates, causing the power supply to eject and potentially resulting in serious personal injury. No reports of this problem occurring on-site due to the incorrect specified value have been received so far.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems, LLC
- Summary: On July 22, 2015, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., in collaboration with GE Medical Systems, initiated a voluntary recall of several imaging products, including Positron Emission Tomography and Computed Tomography (CT) systems. This action was reported to the National Medical Products Administration (NMPA) in China, referencing relevant registration numbers. The recall was prompted by the discovery of an incorrect installation torque value specified for the power supply during replacement procedures for the rotating part of the scanner gantry. This critical error could lead to the power supply's fixing threads becoming overloaded, potentially loosening during gantry rotation, and in extreme cases, causing the power supply to eject outwards, posing a significant risk of serious personal injury. While no on-site incidents or injuries related to this specific defect have been reported, GE Healthcare is implementing proactive measures. The required corrective actions include informing affected customers via email with guidance on safe use and dispatching engineers to perform complimentary, on-site corrections for all impacted devices to ensure patient safety and product integrity.

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