# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/respironics-california-inc/8c138c2c-06db-42ee-8bbc-e9e761999e51/
Source feed: China

> China NMPA product recall for Ventilator by Respironics California, Inc. published May 26, 2017. Recall level: Level 1. The National Medical Products Administration (NMPA) announced on May 26, 2017, a voluntary Class I r

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Respironics California, Inc. Active recall of ventilators.
- Company Name: Respironics California, Inc.
- Publication Date: 2017-05-26
- Product Name: Ventilator
- Recall Level: Level 1
- Recall Reason: The pins of the internal ribbon cable of the ventilator may be partially displaced due to low-frequency vibration, eventually leading to errors and shutdown.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Respironics California, Inc.
- Summary: The National Medical Products Administration (NMPA) announced on May 26, 2017, a voluntary Class I recall initiated by Respironics California, Inc. for its manufactured ventilators. This critical recall, reported by Philips (China) Investment Co., Ltd., addresses a significant safety concern where the pins of the internal ribbon cable within the ventilators may become partially displaced. This displacement is attributed to low-frequency vibrations, which can ultimately cause device errors and unexpected shutdowns. The recall is classified as Class I, signifying that there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. The affected ventilators, identified under Registration Certificate No.: 20163545139, are subject to this urgent corrective action. Respironics California, Inc. is taking proactive steps to mitigate potential risks to patients. Detailed information regarding the specific models, specifications, and batches of the affected medical devices is available in the "E-Recall Event Report Form." This document underscores the regulatory oversight of the NMPA in ensuring the safety and efficacy of medical products distributed within its jurisdiction, requiring manufacturers to take prompt action when product deficiencies are identified. The immediate required action involves the comprehensive recall of all impacted units to prevent patient harm.

Company: https://www.globalkeysolutions.net/companies/respironics-california-inc/74e0ff42-7ab6-4eae-b35d-81406bd7e09a/