# China NMPA Product Recall - X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-shimadzu-medical-devices-co-ltd/bbeaa697-4f1f-4985-9e49-4670bbcb7350/
Source feed: China

> China NMPA product recall for X-ray imaging system by Beijing Shimadzu Medical Devices Co., Ltd. published August 02, 2017. Recall level: Level 3 Recall. Beijing Shimadzu Medical Devices Co., Ltd., under the oversight of the National Medical Products Adm

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Shimadzu Medical Devices Co., Ltd. voluntarily recalls X-ray imaging systems
- Company Name: Beijing Shimadzu Medical Devices Co., Ltd.
- Publication Date: 2017-08-02
- Product Name: X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: The product has an expected service life of 10 years. However, in rare cases, cracks may develop in the fixed shaft of the tube support section (CH-200) if the equipment has been used for more than 10 years or under abnormal conditions. If these cracks continue to widen, they may cause the tube support shaft to break, resulting in tilting of the tube support section. Furthermore, the tube support components on the aforementioned machine were purchased from Shimadzu Corporation of Japan, which has already issued a recall. Therefore, our company is also recalling this product.
- Discovering Company: Beijing Shimadzu Medical Devices Co., Ltd.
- Manufacturing Company: Beijing Shimadzu Medical Devices Co., Ltd.
- Summary: Beijing Shimadzu Medical Devices Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a Class III voluntary recall for its X-ray Imaging Systems (Model: RAD SPEED M, CFDA (Approval) No. 20083301062). This recall, announced on August 2, 2017, stemmed from a report submitted on July 31, 2017. The core issue involves the X-ray tube support component, manufactured by Shimadzu Corporation of Japan, which has an expected service life of 10 years. If the equipment is used beyond this period or under abnormal conditions, a small number of units may develop cracks in the CH-200 section of the X-ray tube support. The primary concern is that these cracks could enlarge, potentially leading to the breakage of the support shaft and subsequent tilting of the X-ray tube support part. Fortunately, no malfunctions or injuries related to this defect have been reported within China. To address the issue, Beijing Shimadzu Medical Devices Co., Ltd. dispatched written communications to affected customers, informing them of the incident and reinforcing the importance of adhering to operational manuals. Furthermore, all five affected units in China are undergoing repair at their installation locations, which includes fitting additional protective parts to reinforce the X-ray tube support shaft. These corrective actions are projected to be completed within two months of the report date.

Company: https://www.globalkeysolutions.net/companies/beijing-shimadzu-medical-devices-co-ltd/3c3cf184-d429-4d2f-a747-c5d5bcbb4c93/