# China NMPA Product Recall - Patient monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/864c7ab0-aacd-4771-aa78-b62355ebd4d0/
Source feed: China

> China NMPA product recall for Patient monitor by Philips (China) Investment Co., Ltd. published March 18, 2021. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its SureSigns VM seri

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls patient monitors.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-03-18
- Product Name: Patient monitor
- Recall Level: Level 2 Recall
- Recall Reason: The upper limit of the heart rate monitor range for patient monitors with software version A.02.63 is 300 bpm. In pediatric mode, when the input signal rate exceeds 300 bpm, the indicated rate of affected products will be lower than this upper limit. This indicates that when the device is used in pediatric mode, the displayed heart rate may be lower than the upper limit when the ECG input signal is higher than the upper limit of the measurement range, causing the device's alarm for this input signal to fail.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its SureSigns VM series patient monitors, as reported by the National Medical Products Administration (NMPA) on March 18, 2021. The recall stems from a critical software issue identified in devices with software version A.02.63. The primary concern is the heart rate monitor's performance in pediatric mode. While the disclosed upper limit for newborn/pediatric mode is 350 bpm, the affected monitors have an internal upper display limit of 300 bpm. Consequently, when the electrocardiogram (ECG) input signal for a pediatric patient exceeds 300 bpm but remains below 350 bpm, the device displays a heart rate lower than the actual input. This discrepancy prevents the device's high heart rate alarm from activating, as the displayed value is below the measurement range's upper threshold. The failure of this crucial alarm poses a potential risk of delayed medical intervention for pediatric patients experiencing dangerously high heart rates. Philips (China) is undertaking this recall to address the non-conformance with safety requirements, providing further details on affected product models and batches in a Medical Device Recall Event Report Form. This action aligns with NMPA's medical device oversight.

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