# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/zall-medical-usa-company/079d7d98-7057-4f2d-a9ca-81d4987229a0/
Source feed: China

> China NMPA product recall for Ventilator by Zall Medical (USA) Company published August 28, 2024. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced on August 28, 2024, that ZOLL Medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ZOLL Medical Corporation (USA) voluntarily recalls ventilators
- Company Name: Zall Medical (USA) Company
- Publication Date: 2024-08-28
- Product Name: Ventilator
- Recall Level: Level 1 Recall
- Recall Reason: The product manual has been revised to change the magnetic field strength value corresponding to the safe distance for using the ventilator in an MRI environment.
- Discovering Company: Zowell Medical Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Zall Medical (USA) Company
- Summary: The National Medical Products Administration (NMPA) announced on August 28, 2024, that ZOLL Medical Corporation (USA), through its subsidiary ZOLL Medical Technology (Shanghai) Co., Ltd., is initiating a voluntary Class I recall of certain ventilators. The recall stems from a critical safety concern regarding changes in the magnetic induction intensity values associated with the safe operating distance for these ventilators within Magnetic Resonance Imaging (MRI) environments.

This issue specifically pertains to information presented in the product instructions, which now indicate a revised safe distance. The affected products are identified under National Medical Device Registration Certificate 20163080928. A Class I recall signifies the most serious type, indicating a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death.

As part of this regulatory action overseen by the NMPA, ZOLL Medical Corporation is required to identify and address all affected ventilator models, specifications, and batches, detailed in a 'Medical Device Recall List' and an 'Event Report Form'. This proactive measure ensures patient safety and compliance with medical device regulations by rectifying discrepancies in device labeling regarding MRI compatibility.

Company: https://www.globalkeysolutions.net/companies/zall-medical-usa-company/379dba1e-22e1-4331-9209-0675a1dc8454/