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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/fa2d1310-e78c-4964-9ed4-237989b4b5e2/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published July 08, 2016. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for 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: 2016-07-08
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: The system will emit a beep from the monitor's speaker when the exposure ends. However, the user may set the monitor volume to "0" by pressing buttons or touch keys on the monitor (the screen will display the current volume value during volume adjustment). In this case, the user will not hear the beep when the exposure ends, which may lead the user to mistakenly believe that the exposure was not performed correctly and may 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 Class III recall for its Digital Medical X-ray Imaging Systems, including models like DuraDiagnost and DuraDiagnost 50SE. The recall was publicly reported on July 8, 2016, stemming from a company report on June 27, 2016. The primary concern is a design flaw allowing the exposure warning sound, which indicates the completion of an X-ray, to be set to '0' volume. If muted, users would not hear the crucial beep, potentially leading them to mistakenly believe the exposure was incomplete and prompting unnecessary patient re-exposure to radiation. No patient injuries linked to this issue have been reported to date.

Operating under the regulatory guidance of the National Medical Products Administration (NMPA) in China, Philips Healthcare (Suzhou) Co., Ltd. has outlined specific corrective actions. The company has proactively notified affected product users through written on-site safety notices. The required action involves implementing an On-Site Corrective Action (FCO71200155) to resolve the identified audio notification deficiency in the affected devices. The recall affects 153 manufactured units, with 40 units distributed within China, and a significant number spread across multiple international markets.

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