Philips recalls certain SureSigns VM4, VM6, and VM8 patient monitors sold in China for potential pediatric heart rate inaccuracies in high-rate scenarios.
Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit
Philips is recalling specific SureSigns patient monitors sold in China due to a risk of inaccurate heart rate readings in pediatric mode when the heart rate exceeds 300 bpm. This could lead to incorrect medical decisions for children.
In pediatric mode, these monitors may display a heart rate lower than the actual rate when the input signal exceeds 300 beats per minute. This could cause healthcare providers to misinterpret a child's condition, potentially delaying critical treatment.
Healthcare providers using Philips SureSigns VM4, VM6, or VM8 monitors in China for pediatric patients. Children with heart rates above 300 bpm are at risk of inaccurate readings.
Check for model numbers 863063-863088 or software version SW A.02.63 on the monitor. These products were sold in China only.
Look for model numbers 863063, 863064, 863065, 863066, 863068, 863085, 863086, or software version SW A.02.63.
These monitors may show inaccurate heart rates in pediatric mode when the input signal exceeds 300 bpm, but they are not unsafe for general use.
Check for model numbers 863063-863088 or software version SW A.02.63 on the monitor. These products were sold in China only.
The recall does not specify a remedy, so contact Philips for further instructions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1326-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-1326-2021 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
