# 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-health-inc-global-rd-center-shanghai/25fde3c5-c899-48d0-a45a-0f68f3c47029/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system: Digital mobile X-ray machine by Carestream Health, Inc., Global R&D Center (Shanghai) published August 08, 2017. Recall level: Level 2 Recall. Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., representing manufacturer Carest

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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 Health, Inc., Global R&D Center (Shanghai)
- Publication Date: 2017-08-08
- Product Name: Digital medical X-ray imaging system: Digital mobile X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: The investigation revealed a risk of loosening in the connection between the X-ray tube and the telescopic arm, which could lead to separation. The investigation found that the equipment experiencing the loosening had its telescopic arm not fitted with the four screws required for securing it, as per manufacturing procedures and requirements.
- Discovering Company: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd.
- Manufacturing Company: Carestream Health, Inc., Global R&D Center (Shanghai)
- Summary: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., representing manufacturer Carestream Health, Inc., issued a voluntary Class II recall for its Digital Medical X-ray Imaging Systems. This action, documented by the National Medical Products Administration (NMPA) on August 8, 2017, addresses a significant safety concern. The core issue involves a risk of the X-ray tube becoming loose from its telescopic arm, potentially leading to separation of the components. An investigation determined that the manufacturing process failed to install four crucial screws required for securing the telescopic arm.

While only one incident of component loosening was reported globally, with no associated personal injuries, Carestream undertook a thorough risk assessment. To uphold user safety, the company decided to initiate the recall. Affected products include the DRXR-1 model, specifically units with serial numbers 800101-800482, encompassing 302 installed units in China, as well as devices worldwide. Carestream's required action involves conducting on-site inspections of all impacted equipment to rectify this manufacturing defect and mitigate any potential safety hazards, demonstrating adherence to medical device regulations.

Company: https://www.globalkeysolutions.net/companies/carestream-health-inc-global-rd-center-shanghai/2b83ea5d-29d5-41b3-b576-305388f58f45/