# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/208dfc92-6001-4910-aeca-a5917b54e267/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published August 30, 2016. Recall level: Level 3 Recall. Philips Medical (Suzhou) Co., Ltd., also identified as Philips Healthcare (Suzhou) Co., Ltd., initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. voluntarily recalls digital medical X-ray imaging systems
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2016-08-30
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Due to a firmware malfunction in the flat panel detector (Pixium 4343RG model) of this system, the detector may incorrectly display as ready to acquire images when it is not actually ready. This problem may occur intermittently for very short periods, causing the system to fail to acquire X-ray exposure images correctly.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Medical (Suzhou) Co., Ltd., also identified as Philips Healthcare (Suzhou) Co., Ltd., initiated a voluntary Class III recall for its Digital Medical X-ray Imaging Systems, specifically models within the DuraDiagnost series. This action, reported to the National Medical Products Administration (NMPA) on May 5, 2016, and publicly announced on August 30, 2016, addresses a critical internal firmware malfunction in the Pixium 4343RG flat panel detector. The primary issue is the system's intermittent and incorrect display of readiness for image acquisition, which can lead to the failure of X-ray exposure image capture. Fortunately, no patient injuries have been reported as a result of this anomaly.

The recall falls under the regulatory purview of the NMPA. To rectify the problem, Philips is implementing a Field Corrective Action (FCO71200131). The company has already issued field safety notices to users and will dispatch its after-sales service engineers. These engineers are tasked with providing a complimentary software upgrade to all 55 affected units globally, including 10 units distributed in China, once the necessary software package becomes available. This measure aims to resolve the firmware issue, ensuring the continued safe and accurate operation of these medical devices.

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-suzhou-co-ltd/f697ee6b-76f7-4128-9e8c-71e7ebe08572/