# China NMPA Product Recall - Digital medical X-ray imaging system, digital mobile X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/carestream-asia-pacific-investment-management-shanghai-co-ltd/81b234a9-ff4f-4392-93dc-19d01f0edd73/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system, digital mobile X-ray machine by Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. published July 14, 2017. Recall level: Level 2 Recall. Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. initiated a voluntary Class II re

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. has initiated a voluntary recall of products including digital medical X-ray imaging systems.
- Company Name: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Digital medical X-ray imaging system, digital mobile X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: There is a risk of loosening in the connection between the X-ray tube and the telescopic arm, which could lead to separation of the X-ray tube and the telescopic arm.
- Discovering Company: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd.
- Manufacturing Company: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd.
- Summary: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Digital Medical X-ray Imaging Systems and Digital Mobile X-ray Machines, as reported by the National Medical Products Administration (NMPA) on July 14, 2017. The recall was prompted by a critical safety concern: the potential for the connection between the X-ray tube and the telescopic arm to loosen, which could result in the complete separation of these components. This issue poses a significant safety risk to users and patients. The affected products include specific batches of X-ray imaging systems and digital mobile X-ray machines, registered under CFDA (Imported) No. 20132304668 and CFDA Import Registration No. 20142305500. Carestream voluntarily undertook this action to address the identified product defect and ensure patient safety. Further details regarding the precise specifications and batches of the impacted devices are available in the company's Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/carestream-asia-pacific-investment-management-shanghai-co-ltd/0330ee38-b02f-4ea7-80f4-d342692135b9/