# China NMPA Product Recall - X-ray stereotactic radiosurgery system

Source: https://www.globalkeysolutions.net/records/china_product_recall/accuray-incorporated/067988ee-9e23-4582-a1a8-08c284ca8327/
Source feed: China

> China NMPA product recall for X-ray stereotactic radiosurgery system by Accuray Incorporated published April 21, 2016. Recall level: Level II. Accuray Medical Equipment (Shanghai) Co., Ltd., on behalf of manufacturer Accuray Incorporated, init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Acry Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling its X-ray stereotactic radiosurgery system.
- Company Name: Accuray Incorporated
- Publication Date: 2016-04-21
- Product Name: X-ray stereotactic radiosurgery system
- Recall Level: Level II
- Recall Reason: In extremely rare cases, the electron gun control box fixation bracket of an X-ray stereotactic radiosurgery system may fail to support its weight in the vertical position (reverse orientation). If this occurs, the electron gun control box may loosen and fall, potentially contacting the patient. Fixation bracket malfunctions are highly unlikely. To date, no injuries have been reported globally.
- Discovering Company: Acry Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Accuray Incorporated
- Summary: Accuray Medical Equipment (Shanghai) Co., Ltd., on behalf of manufacturer Accuray Incorporated, initiated a Class II voluntary recall of its X-ray Stereotactic Radiosurgery System, specifically the CyberKnife VSI model. The recall, reported on February 3, 2016, and published by the National Medical Products Administration (NMPA) on April 21, 2016, addresses a potential safety issue with the electron gun control box fixation bracket. In rare instances, the bracket may fail to support the weight of the electron gun control box in the vertical position. Should this occur, the control box could loosen and fall, potentially coming into contact with a patient. The affected products, encompassing 12 production quantities and 23 sales quantities in China, are identifiable by specific batch numbers including C0258, C0271, and others, with the recall spanning global regions. Accuray has issued an emergency safety alert to users of the relevant systems, committing to assist customers with inspections and to replace the faulty electron gun control box mounting bracket. No injuries related to this issue have been reported worldwide to date.

Company: https://www.globalkeysolutions.net/companies/accuray-incorporated/c9522dd3-9d5c-4b99-810c-6395331e103c/