Philips SureSigns Patient Monitors Recalled for Pediatric Heart Rate Accuracy Issues
Philips is recalling SureSigns VM4, VM6, and VM8 patient monitors in China because they fail to meet Chinese standards for heart rate accuracy in pediatric mode.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a specific accuracy failure in a monitoring device without reported injuries or deaths, fitting the criteria for a moderate severity precautionary or compliance recall.
Plain-English summary
Philips North America, LLC is recalling 31,773 units of SureSigns VM4, VM6, and VM8 patient monitors. These devices are used in healthcare environments to monitor, record, and alarm for multiple physiological parameters in adults, pediatrics, and neonates. The recall is limited to units distributed internationally in China.
The recall was initiated because the products fail to comply with Chinese Standard YY1079-2008, specifically Clauses 4.2.6 and 4.2.7.3. In pediatric mode, when the input signal rate is over 300 beats per minute, the indicated heart rate on the affected products is lower than the upper limit. This inaccuracy could affect the monitoring of patients in this specific mode.
Healthcare facilities in China that have these specific models (863063, 863064, 863065, 863066, 863068, 863085, 863086, 863087, 863088, and associated serial numbers) should contact Philips for instructions on how to address the non-compliance. The affected software version is SW A.02.63.
The recalled product
- Product
- Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 31,773
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version: SW A.02.63
Distribution
Distribution scope not specified by the agency.
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