# China NMPA Product Recall - Image processing software NX 3.0

Source: https://www.globalkeysolutions.net/records/china_product_recall/agfa-medical-systems-shanghai-co-ltd/4a84b367-eb5e-41c3-ba90-4f72e8b4fdaa/
Source feed: China

> China NMPA product recall for Image processing software NX 3.0 by Agfa Medical Systems (Shanghai) Co., Ltd. published March 01, 2017. Recall level: Level III. The National Medical Products Administration (NMPA) published a voluntary Level III recall notice on

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Agfa Medical Systems (Shanghai) Co., Ltd. is voluntarily recalling its NX3.0 image processing software.
- Company Name: Agfa Medical Systems (Shanghai) Co., Ltd.
- Publication Date: 2017-03-01
- Product Name: Image processing software NX 3.0
- Recall Level: Level III
- Recall Reason: Due to a memory issue, the system displays warning messages to the user regarding unexpected errors and potentially incorrect data integrity. Restarting the workstation computer after receiving the warning message can prevent the problem from occurring. In one instance abroad, failure to follow the warning instructions resulted in one patient's image being archived in another patient's record.
- Discovering Company: Agfa Medical Systems (Shanghai) Co., Ltd.
- Manufacturing Company: Agfa Medical Systems (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) published a voluntary Level III recall notice on March 1, 2017, initiated by Agfa Medical Systems (Shanghai) Co., Ltd., regarding their NX3.0 Image Processing Software. The company reported the defect on January 23, 2017. The primary issue identified was a critical software defect causing patient images to be potentially archived in another patient's record under extreme circumstances. This problem is attributed to a memory issue, which also leads to unexpected error warning messages and potential data integrity concerns. The affected product, registered under CFDA (Imported) No. 2013 2702972, is utilized for digital image acquisition, processing, and transmission. Seven demonstration units were impacted across various regions, including Asia, New Zealand, India, Thailand, and Hong Kong. No units had been sold to customers. Agfa Healthcare (Shanghai) Co., Ltd. implemented immediate corrective actions, advising customers to restart their NX workstations daily to prevent memory issues and to restart the system immediately if any warning messages appear. Additionally, the company committed to releasing a new software version, NX 3.0.9000, to provide a permanent solution to these identified problems.

Company: https://www.globalkeysolutions.net/companies/agfa-medical-systems-shanghai-co-ltd/62f9cc32-3e79-46c5-a6f4-293cc958e719/