# China NMPA Product Recall - Neonatal/pediatric ventilators, neonatal and infant ventilators

Source: https://www.globalkeysolutions.net/records/china_product_recall/acutronic-medical-systems-ag/f8da0fef-ad86-4914-991a-bda20cc68048/
Source feed: China

> China NMPA product recall for Neonatal/pediatric ventilators, neonatal and infant ventilators by ACUTRONIC Medical Systems AG published May 14, 2019. Recall level: Level 3 Recall. ACUTRONIC Medical Systems AG, supported by its Chinese agent Beijing Jingbo Technology Development C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ACUTRONIC Medical Systems AG is issuing a voluntary recall for neonatal/pediatric ventilators and neonatal/infant ventilators.
- Company Name: ACUTRONIC Medical Systems AG
- Publication Date: 2019-05-14
- Product Name: Neonatal/pediatric ventilators, neonatal and infant ventilators
- Recall Level: Level 3 Recall
- Recall Reason: A manufacturing defect in the front panel membrane cover may cause a short circuit in the panel buttons; when the device is connected to Ethernet, the graphical user interface may freeze or crash, or may cause the device to stop patient ventilation alarm; when the volume assurance function is enabled, patient weaning may not trigger the patient weaning alarm; the peak airway pressure (PIP) high limit alarm and the automatic airway depressurization function are not related, the PIP high limit alarm is only used to inform the user that the peak airway pressure is high, this information is provided in the instruction manual.
- Discovering Company: Beijing Jingbo Technology Development Co., Ltd.
- Manufacturing Company: ACUTRONIC Medical Systems AG
- Summary: ACUTRONIC Medical Systems AG, supported by its Chinese agent Beijing Jingbo Technology Development Co., Ltd., has initiated a voluntary Level III recall for its neonatal/pediatric and neonatal/infant ventilators. This action, reported to the National Medical Products Administration (NMPA) on May 10, 2019, addresses identified product deficiencies. The core issues include a manufacturing defect in the front panel membrane, which could cause button short circuits. Furthermore, several software anomalies were found: the graphical user interface may freeze or crash when connected to Ethernet, potentially disabling critical ventilation alarms; the volume assurance function might fail to trigger patient weaning alarms; and the instruction manual requires clarification on the peak airway pressure (PIP) high limit alarm. As corrective actions, ACUTRONIC is notifying all distributors and users. Company personnel will perform on-site rectifications, which include replacing defective front panels on 115 identified units and implementing necessary software updates and upgrades across all 1631 affected ventilators to resolve functional shortcomings. Instruction manuals will also be updated. Although no patient harm has been reported in China, this voluntary recall underscores adherence to the NMPA's medical device safety standards.

Company: https://www.globalkeysolutions.net/companies/acutronic-medical-systems-ag/a628c90f-882e-41b9-b2b1-567bfabfe50d/