# China NMPA Product Recall - X-ray computed tomography equipment, X-ray computed tomography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/d462d110-addf-4a31-b97e-9092ccbc38de/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment, X-ray computed tomography equipment by Philips (China) Investment Co., Ltd. published July 14, 2017. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for several models of it

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. has initiated a voluntary recall of products including X-ray computed tomography (CT) equipment.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: X-ray computed tomography equipment, X-ray computed tomography equipment
- Recall Level: Level 3 Recall
- Recall Reason: The "Impressions" section of the calcification scoring report from the scanner's software provides inappropriate information.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for several models of its X-ray computed tomography (CT) equipment, as announced by the National Medical Products Administration (NMPA) on July 14, 2017. This critical action was prompted by the discovery of inappropriate information within the "Impressions" section of the calcification scoring report, a key component of the scanner software in the affected devices. This software anomaly specifically impacted CT equipment registered under numbers 20163301984, 20153302507, and 20153300422, among others for which detailed specifications were provided in an accompanying Medical Device Recall Event Report Form. The presence of incorrect data in such a vital diagnostic report could potentially influence clinical assessments, underscoring the seriousness of the issue. Philips (China) took immediate steps to rectify this product deficiency, demonstrating its adherence to medical device safety standards established by the NMPA. The voluntary nature of the recall highlights the company's proactive commitment to ensuring the reliability and accuracy of its medical imaging products, thereby safeguarding patient care and upholding the integrity of diagnostic information generated by these advanced CT systems. This measure reinforces the importance of stringent software validation and ongoing post-market surveillance for medical devices.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/