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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/b1fb8178-1838-4517-80ac-3ac1dee67792/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published July 19, 2017. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a Class III voluntary recall of its Digital Medical 

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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: 2017-07-19
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Due to an internal firmware malfunction in the fixed-panel detector (model Pixium 4343RC), 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 Healthcare (Suzhou) Co., Ltd. initiated a Class III voluntary recall of its Digital Medical X-ray Imaging Systems, including models such as DigitalDiagnost Power and DigitalDiagnost Pro. This recall was reported to the National Medical Products Administration (NMPA) on June 23, 2017, and subsequently published on July 19, 2017. The core issue stems from an internal firmware malfunction in the Pixium 4343RC fixed flat panel detector. This defect causes the system to incorrectly signal readiness for image acquisition, potentially leading to a failure in correctly capturing X-ray exposure images. The recall impacts 109 units sold in China, with broader distribution across Australia and New Zealand, all designated for clinical X-ray imaging diagnosis. While the malfunction could affect diagnostic capabilities, no related injuries have been reported to date. To resolve this, Philips plans to provide a complimentary software upgrade for all affected systems. Philips after-sales service engineers will proactively contact customers to arrange and implement the necessary corrective software update.

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