# China NMPA Product Recall - Revolution CT

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-llc/db9220f2-d130-4a56-97a2-2f005406dbff/
Source feed: China

> China NMPA product recall for Revolution CT by GE Medical Systems, LLC published July 06, 2016. Recall level: Level II. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., on behalf of manufacturer GE Medical

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling its whole-body X-ray computed tomography (CT) system.
- Company Name: GE Medical Systems, LLC
- Publication Date: 2016-07-06
- Product Name: Revolution CT
- Recall Level: Level II
- Recall Reason: Unexpected movement of the Revolution CT scanning table may occur during large patient scans, and the scanning bed may drop during user operation. Risks include the possibility of hand injury if the patient's hand is positioned between the bed entry device and the gantry bore.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems, LLC
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., on behalf of manufacturer GE Medical Systems, LLC, initiated a voluntary Class II recall for its Revolution CT Whole-Body X-ray Computed Tomography System. This action, reported to the National Medical Products Administration (NMPA) on May 12, 2016, and published July 6, 2016, addresses a critical safety concern. The primary issue identified is the potential for the Revolution CT scanning bed to move unexpectedly during scans of large patients, and for the scanning bed plate to drop during user operation. While no injuries have been reported, this malfunction presents a potential risk of hand injury if a patient's hand is positioned between the bed entry device and the gantry bore. Affected products were distributed across various regions, including the USA, Australia, Canada, and China. To mitigate these risks, GE Healthcare implemented corrective actions, including sending direct email communications to customers to inform them of the issue and provide guidance on safe use. Additionally, the company committed to deploying engineers to customer sites to perform complimentary modifications and corrections on all affected units, ensuring the safety and proper functionality of the Revolution CT systems in compliance with NMPA's regulatory standards.

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