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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/d3e3e658-26b6-4618-99f4-ae32e02d6662/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Healthcare (Suzhou) Co., Ltd. published July 18, 2017. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level III recall of its Digital Medical 

---

## 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: 2017-07-18
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: An internal firmware malfunction in the fixed flat panel detector (model Pixium 4343RC) may cause the detector to incorrectly display as ready to acquire images when it is not actually ready. This issue may occur intermittently for very short periods, resulting in the system failing 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 voluntary Level III recall of its Digital Medical X-ray Imaging Systems, reported to the National Medical Products Administration (NMPA) on June 23, 2017, and publicly announced on July 18, 2017. The recall affects models including DigitalDiagnost Power, DigitalDiagnost Power 80, and DigitalDiagnost Pro, used for clinical X-ray imaging. The core issue stems from an internal firmware malfunction within the Pixium 4343RC fixed flat panel detector. This defect causes the detector to intermittently display as ready for image acquisition when it is not, leading to potential failures in correctly acquiring X-ray exposure images. While no injuries have been reported, this issue requires corrective action under the NMPA's regulatory oversight, referencing specific medical device approval numbers. Philips Healthcare (Suzhou) Co., Ltd. will resolve the problem by providing a free software upgrade for all affected systems. Their after-sales service engineers will proactively contact customers in impacted regions, including China, Australia, and New Zealand, to schedule and implement the necessary software installation. A total of 123 units were manufactured, with 109 units sold in China.

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