# China NMPA Product Recall - X-ray computed tomography equipment (incisive CT, MX16-slice and Access CT scanning beds)

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/5095321b-181a-4219-bb9c-6f7f6e4c0563/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment (incisive CT, MX16-slice and Access CT scanning beds) by Philips Healthcare (Suzhou) Co., Ltd. published February 25, 2021. Recall level: Level 2 Recall. Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class II recall for specific X-ray Compu

---

## 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: 2021-02-25
- Product Name: X-ray computed tomography equipment (incisive CT, MX16-slice and Access CT scanning beds)
- Recall Level: Level 2 Recall
- Recall Reason: A problem exists with the pushrod motors installed in some Incisive CT, MX16-slice, and Access CT scanning beds, which may cause the scanning bed to move downwards unexpectedly and slowly.
- Discovering Company: Philips Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class II recall for specific X-ray Computed Tomography (CT) equipment models, including Incisive CT, MX16-slice, and Access CT scanning beds. The recall, publicized on February 25, 2021, follows internal testing that revealed a critical defect: pushrod motors in these scanning beds may cause unexpected and slow downward movement, posing a potential safety risk. This proactive measure is being implemented under the regulatory framework of the National Medical Products Administration (NMPA), with the initial notification appearing via the Jiangsu Provincial Drug Administration. The Class II designation indicates that the issue could lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Required actions involve the immediate implementation of this recall, with comprehensive details regarding the specific affected products and the scope of the recall available in a designated "Medical Device Recall Event Report Form." This action underscores the company's commitment to ensuring patient safety and product reliability.

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