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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/af65f356-db22-428c-9a15-d589ee23ea27/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published December 23, 2016. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III 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: 2016-12-23
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: 1) Due to a firmware malfunction in the flat panel detector (Pixium 4343RG model) of the system, the flat panel 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. 2) The system emits an audible alert from the monitor's speaker when the exposure ends. However, the user may have set the monitor volume to "0" using buttons or touch keys on the monitor (the current volume value is displayed on the screen during volume adjustment). In this case, the user will not hear the alert when the exposure ends, which may lead the user to mistakenly believe that the exposure was not performed correctly and potentially prompt them to re-expose the patient.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Digital Medical X-ray Imaging Systems, reported to the National Medical Products Administration (NMPA) on December 15, 2016, and publicly announced on December 23, 2016. The recall addresses two critical technical issues. The first involves an internal firmware anomaly in the Pixium 4343RG flat panel detector, which can intermittently cause the system to incorrectly display readiness for image acquisition, resulting in failed X-ray exposures. The second issue pertains to the exposure termination prompt sound; if the monitor volume is set to zero, users may not hear this essential alert, potentially leading to unnecessary patient re-exposure due to the belief that the initial exposure failed. Although these issues could impact diagnostic accuracy or increase patient radiation, no injuries have been reported. Under the NMPA's regulatory framework, Philips Healthcare (Suzhou) Co., Ltd. has taken required actions by notifying affected customers via a field safety notice and will implement a Field Corrective Action (FCO). Philips after-sales service engineers will provide a free software upgrade package to resolve the firmware and audio notification issues for all affected units, including 61 devices in China and others distributed globally.

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