# China NMPA Product Recall - Medical magnetic resonance imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/807fed59-9aae-4d99-abd2-75b868bb9767/
Source feed: China

> China NMPA product recall for Medical magnetic resonance imaging system by Philips (China) Investment Co., Ltd. published August 18, 2021. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its medical magnetic 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling medical magnetic resonance imaging systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-08-18
- 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 immobile. This problem only occurs in manual mode because of the interaction between the gear teeth and the Flexrack of the Horizontal Drive Unit (HDU). In an MR system HDU, if both a non-circular gear tooth profile and a slightly bent Flexrack are present simultaneously, the scan bed will jam.
- 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 its medical magnetic resonance imaging (MRI) systems, as reported by the National Medical Products Administration (NMPA) on August 18, 2021. The recall stems from an identified issue where the scanning bed may jam and become immobile when operated in manual mode.  The core problem involves the Horizontal Drive Unit (HDU), which primarily uses electric power for bed movement and manual function as a backup for emergencies or electric failure. The jamming occurs specifically in manual mode if two conditions are simultaneously present: the gear teeth are not perfectly circular, and the Flexrack is slightly bent. This combination can obstruct the outward movement of the bed. Crucially, this issue is confined to manual operation, as the contact points between the gear teeth and Flexrack differ when using the electric function, which remains unaffected. Philips discovered this potential malfunction internally, and as of July 2021, had not received any user complaints related to the specific issue. The voluntary recall, indexed as JGXX-2021-10449, falls under the regulatory oversight of the NMPA, with details on affected product models, specifications, and batches provided in the accompanying "Medical Device Recall Event Report Form." This action ensures compliance with medical device safety standards and proactively addresses a potential operational concern for users of the affected MRI systems.

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