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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/74cbc582-aff6-44b5-8a55-38e952d56c69/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips Healthcare (Suzhou) Co., Ltd. published October 09, 2017. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its Ingenuity Core 

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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: 2017-10-09
- Product Name: X-ray computed tomography equipment
- Recall Level: Level 3 Recall
- Recall Reason: In Ingenuity Core 128 software version 4.1.6, images cannot be generated during the contrast agent tracking scan in CT, resulting in the inability to obtain raw data for offline reconstruction. If this problem occurs again, the CT scan will need to be re-executed.
- 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 Ingenuity Core 128 X-ray Computed Tomography Equipment. This action, reported on September 27, 2017, and published by the National Medical Products Administration (NMPA) on October 9, 2017, addresses a critical software issue. The main problem stems from software version 4.1.6, which prevents image generation during contrast agent tracking scans. This failure leads to an inability to obtain raw data for offline reconstruction, potentially requiring repeat CT scans for patients. The recall falls under the regulatory oversight of the NMPA, indicating adherence to Chinese medical device regulations, with the product originally approved under CFDA (Approval) No. 20133301488. Philips Healthcare (Suzhou) Co., Ltd. responded by issuing on-site safety notification letters to affected users and implementing specific on-site improvement measures (FCO72800675) to correct the software defect. A total of 47 affected units were distributed and subsequently addressed in China to ensure the equipment's reliability for diagnostic purposes.

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