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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/c29e2766-b015-4b73-a8fa-4e4e165f939b/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips Healthcare (Suzhou) Co., Ltd. published August 24, 2017. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall of its X-ray computed t

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. voluntarily recalls X-ray computed tomography equipment.
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2017-08-24
- Product Name: X-ray computed tomography equipment
- Recall Level: Level 3 Recall
- Recall Reason: The system encountered an error when reaching the threshold during a non-gated contrast agent bolus tracking clinical scan, displaying the error message "An error has occurred. Please try again. If the problem recurs, please contact customer service." This resulted in the cancellation of the scan sequence and loss of contrast agent. If this problem occurs again, a rescan may be necessary. This issue may affect systems running software versions 4.1.6.XX030 or 4.1.6.XX032.
- 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 X-ray computed tomography equipment (model Ingenuity Core 128), as reported on August 22, 2017, and published by the National Medical Products Administration (NMPA) on August 24, 2017. This action addresses a significant system error affecting 47 units within China. The primary issue occurs during non-gated contrast agent bolus tracking clinical scans. When the system reaches a specific threshold, it generates an error message, causing the scan sequence to cancel and leading to the loss of contrast agent. This malfunction potentially necessitates a rescan and impacts systems running software versions 4.1.6.XX030 or 4.1.6.XX032. Under the NMPA's regulatory framework, Philips Healthcare (Suzhou) Co., Ltd. responded by issuing a field safety notification and a specific field improvement measure (FCO72800675) to correct the software defect. Additionally, all customers with the affected equipment received direct notification letters to ensure timely resolution and maintain diagnostic reliability.

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