# China NMPA Product Recall - Monitor defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/b1b3c92d-2312-498f-88a2-877b52c0bc74/
Source feed: China

> China NMPA product recall for Monitor defibrillator by Philips Medical Systems published November 03, 2017. Recall level: Level 2 Recall. Philips Medical Systems (Philips China) Investment Co., Ltd. initiated a voluntary Class II recall o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems initiates voluntary recall of monitor defibrillators.
- Company Name: Philips Medical Systems
- Publication Date: 2017-11-03
- Product Name: Monitor defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: When operating the EtCO2 monitoring function, if an EtCO2 measurement cannot be obtained, the affected module will warn the user (by displaying a dashed line in the waveform graph and a question mark in the parameter text box). This problem may expose the patient to certain dangerous situations due to the following reasons: No carbon dioxide plethysmogram is displayed, which may prevent the identification of intubation/ventilation problems; CO2/respiratory rate cannot be monitored; EtCO2 is not displayed, and the user must rely on other parameters to adjust the ventilation rate and depth.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems (Philips China) Investment Co., Ltd. initiated a voluntary Class II recall of its monitored defibrillators (models M3535A, M3536A), as reported by the National Medical Products Administration (NMPA) on November 3, 2017, based on a report dated October 9, 2017. The recall addresses a critical safety concern where the EtCO2 monitoring function may fail to obtain measurements. This issue poses a significant risk to patients by potentially hindering the identification of crucial intubation or ventilation problems, impeding the monitoring of CO2 and respiratory rates, and forcing medical personnel to rely on less precise parameters for ventilation adjustments, despite the device displaying a warning. The affected devices, registered under National Medical Device Registration Certificate 20163214004, are designed for various life-sustaining functions including defibrillation, cardioversion, pacing, and multi-parameter monitoring. Although classified as a Class II recall, the specific affected batches were not sold in China. Consequently, no corrective actions or affected units were reported for the Chinese market, as indicated by the 'Not Applicable' status for recall requirements and handling methods within China. The recall primarily impacts regions including Canada, South Africa, and the USA, where these units were distributed.

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