# China NMPA Product Recall - Medical Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/a9c0601b-7de6-4a60-ac97-e712b6db9b5d/
Source feed: China

> China NMPA product recall for Medical Magnetic Resonance Imaging System by Philips Medical Systems published June 09, 2021. Recall level: Level 2 Recall. Philips Medical Systems Nederland B.V. initiated a voluntary Class II recall of its Medical Magnetic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems Nederland B.V. is voluntarily recalling its Magnetic Resonance Equipment (MRE) systems.
- Company Name: Philips Medical Systems
- Publication Date: 2021-06-09
- Product Name: Medical Magnetic Resonance Imaging System
- Recall Level: Level 2 Recall
- Recall Reason: The diameter of the bolt face of the swivel eye bolt, used as lifting hardware, does not meet the requirements, and the thread pitch error exceeds the tolerance range. This results in incomplete engagement between the thread of the swivel eye bolt and the bolt face, posing a potential risk of bolt breakage.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems Nederland B.V. initiated a voluntary Class II recall of its Medical Magnetic Resonance Imaging Systems. This action, reported by Philips (China) Investment Co., Ltd. and overseen by China's National Medical Products Administration (NMPA), was publicly announced on June 9, 2021, with the official recall event report form dated May 25, 2021.

The core issue identified was a manufacturing defect concerning the rotating eye bolt, a critical lifting hardware component. Specifically, the diameter of the bolt interface face did not meet the required specifications for certain models and batches of the equipment. This non-conformance could potentially impact the safe handling or installation of the devices, posing a risk of temporary or medically reversible adverse health consequences.

As a corrective measure, Philips Medical Systems Nederland B.V. is conducting this Class II recall. The company has submitted a "Medical Device Recall Event Report Form" outlining the affected products, specifications, and batches, and detailing the Field Safety Corrective Action (FCO78100524) taken to address this manufacturing deviation. This recall ensures compliance with regulatory standards and aims to mitigate potential risks associated with the faulty component.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/