# China NMPA Product Recall - Image archiving and transmission system, image archiving and transmission software

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/17f33175-c673-47ed-b3cd-9c01e09082ba/
Source feed: China

> China NMPA product recall for Image archiving and transmission system, image archiving and transmission software by GE Healthcare (China) Co., Ltd. published October 31, 2018. Recall level: Level 2 Recall. GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare proactively recalls its image archiving and transmission system and software.
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2018-10-31
- Product Name: Image archiving and transmission system, image archiving and transmission software
- Recall Level: Level 2 Recall
- Recall Reason: GE Healthcare recently discovered a potential database processing issue during image acquisition in some batches of its products, which could affect the integrity of the acquired images. The potential risk is that examinations may be missing one or more image sequences. While this issue is rare, it can still occur even when the number of images in each sequence is small.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its Centricity Universal Viewer Image Archiving and Transmission Systems and Software (versions 5.0 and 6.0). The company reported this action on April 4, 2018, with the National Medical Products Administration (NMPA) publishing the notice on October 31, 2018. The recall was prompted by a potential database processing issue identified during the image acquisition process. This flaw could affect the integrity of acquired medical images, potentially resulting in one or more missing image sequences from an examination. Despite the issue being rare and with no reported injuries, GE Healthcare prioritized patient safety and product quality by proactively addressing the concern. Under the NMPA's regulatory framework for medical device registration, GE Healthcare formally reported the incident. As the affected product batches were not sold within China, no physical recall of units was required domestically. The primary action for the Chinese market was the mandated reporting of the incident to the State Food and Drug Administration, ensuring regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/