# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.keypedia.com/records/china_product_recall/philips-china-investment-co-ltd/1390c3ec-54e5-4ebf-a47b-9798e42bbe30
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips (China) Investment Co., Ltd. published August 20, 2021. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific medical magn

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling medical magnetic resonance imaging (MRI) systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-08-20
- Product Name: Medical magnetic resonance imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Using manual mode may cause the scan bed to jam and become unable to move. This is due to the interaction between the gear teeth and the Flexrack of the Horizontal Drive Unit (HDU). In an MR system HDU, the scan bed may jam if both of the following conditions are met simultaneously: 1) the gear teeth are not circular, and 2) the Flexrack is slightly bent. When both conditions occur simultaneously, the outward movement of the bed surface may be blocked when using manual mode.
- 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 of specific medical magnetic resonance imaging (MRI) systems, publicly announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 20, 2021. This proactive measure addresses a potential defect within the MRI system's horizontal drive unit (HDU). The core issue involves the scanning bed potentially jamming and becoming immobile exclusively when operating in manual mode. This malfunction is attributed to the interaction between non-circular gear teeth and a slightly bent Flexrack. Notably, this problem does not affect the system's electric mode, which is the primary operational method. The manual function is intended as a backup for emergency patient evacuation or when electric movement is impaired. Despite no customer complaints related to this specific issue as of July 2021, Philips is undertaking this recall to mitigate any potential safety risks. Comprehensive details regarding the affected product models and batches are provided in an accompanying Medical Device Recall Event Report Form, ensuring adherence to regulatory standards.

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