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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/f4146b6f-7544-4919-bfbf-ad74b4f49796/
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. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class 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 Reason: The system emits a "whoosh" sound from the monitor's speakers when the exposure ends. However, this sound will not be heard when the monitor volume is set to "0". If the sound is not heard, the user may mistakenly believe the exposure was not performed correctly and decide to re-expose the patient, resulting in unnecessary radiation exposure.
- 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 of its Digital Medical X-ray Imaging Systems (Registration No.: 20132301545) in China, as overseen by the National Medical Products Administration (NMPA). Announced on December 23, 2016, the recall addresses an issue where the exposure termination warning sound becomes inaudible if the monitor volume is set to zero. This defect presents a risk of unnecessary patient radiation exposure, as users might mistakenly believe an exposure failed and re-expose the patient. The recall impacts 30 units of the Primary Diagnost DR system, identified by specific product numbers ranging from SN160033 to SN160070. Philips Healthcare (Suzhou) Co., Ltd. has confirmed that no injuries have been reported in connection with this issue. The required actions include notifying affected users through a field safety notice and implementing a Field Corrective Action (FCO) to rectify the problem in all impacted devices.

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