# China NMPA Product Recall - X-ray diagnostic equipment (trade name: Navigator); Kodak DirectView DR3000 digital radiography system (model: DR 3000 / Kodak DirectView DR 3500)

Source: https://www.globalkeysolutions.net/records/china_product_recall/carestream-shanghai-medical-devices-co-ltd/fc724172-ce0f-4767-9096-51f3b208ad06/
Source feed: China

> China NMPA product recall for X-ray diagnostic equipment (trade name: Navigator); Kodak DirectView DR3000 digital radiography system (model: DR 3000 / Kodak DirectView DR 3500) by Carestream (Shanghai) Medical Devices Co., Ltd. published January 19, 2020. Recall level: Level 2 Recall. Carestream (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for specific m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carestream (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling the following products: X-ray diagnostic equipment (trade name: Navigator); X-ray diagnostic equipment (trade name: Navigator); Kodak DirectView DR3000 digital radiography system; Kodak DirectView DR3000 digital radiography system.
- Company Name: Carestream (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2020-01-19
- Product Name: X-ray diagnostic equipment (trade name: Navigator); Kodak DirectView DR3000 digital radiography system (model: DR 3000 / Kodak DirectView DR 3500)
- Recall Level: Level 2 Recall
- Recall Reason: A potential safety issue has been discovered with the product: if the factory settings of the "height inverter," the component that controls the up-and-down movement of the U-arm, are incorrect, and the technician presses the "lower" button on the U-arm multiple times during operation, it could cause unintended movement of the U-arm, potentially resulting in accidental injury to the user or patient.
- Discovering Company: Carestream (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Carestream (Shanghai) Medical Devices Co., Ltd.
- Summary: Carestream (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for specific models of its X-ray diagnostic equipment, including the Navigator and Kodak DirectView DR3000/DR3500 Digital Radiography Imaging Systems. This action, reported via a Shanghai Food and Drug Administration Medical Device Notice on January 19, 2020, addresses a significant safety concern. The issue stems from potentially incorrect factory settings of the "height inverter," a critical component that controls the U-arm's vertical movement. If a technician repeatedly presses the "lower" button on the U-arm, this defect could lead to unexpected U-arm motion. Such uncontrolled movement poses a risk of accidental injury to both users and patients during operation. The recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) and its local affiliate, the Shanghai Food and Drug Administration. Carestream's required action is to conduct this voluntary recall, with specific details on affected product models and batches provided in an accompanying Medical Device Recall Event Report Form. This measure aims to mitigate the identified safety hazard and ensure patient and user safety.

Company: https://www.globalkeysolutions.net/companies/carestream-shanghai-medical-devices-co-ltd/e0534b35-575d-4094-b2fa-410222f92189/