# China NMPA Product Recall - HeartStart XL+ Defibrillator/Monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/53e69435-95a0-4fe8-b781-afdb15b91e9c/
Source feed: China

> China NMPA product recall for HeartStart XL+ Defibrillator/Monitor by Philips (China) Investment Co., Ltd. published November 15, 2019. Recall level: Level 2 Recall. On November 15, 2019, Philips (China) Investment Co., Ltd. announced a voluntary Class II recall con

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls defibrillators/monitors.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-11-15
- Product Name: HeartStart XL+ Defibrillator/Monitor
- Recall Level: Level 2 Recall
- Recall Reason: The product in question may fail to return to the "ready for use" state due to the defibrillator/monitor failing to start or unexpectedly restarting. This issue may also occur when the device is in standby mode and attempts to activate the self-test, resulting in the device indicating that it is not ready, which may delay the delivery of treatment to the patient.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: On November 15, 2019, Philips (China) Investment Co., Ltd. announced a voluntary Class II recall concerning its HeartStart XL+ defibrillator/monitor products. This critical corrective action was reported within the regulatory framework of the National Medical Products Administration (NMPA), with specific reference to the Shanghai Food and Drug Administration's Medical Device Recall No. 2019-277. The core issue prompting this recall is the device's potential to fail to start, unexpectedly restart, or present a "Not Ready" status during self-testing when in standby mode. These malfunctions prevent the defibrillator/monitor from being immediately available for use, posing a significant risk of delaying urgent medical intervention for patients. To mitigate potential patient harm, Philips (China) Investment Co., Ltd. is undertaking this recall. Comprehensive details regarding the affected product models, specifications, and specific manufacturing batches are outlined in the accompanying "Medical Device Recall Event Report Form," ensuring transparency and enabling healthcare providers to identify and address impacted devices effectively.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/