Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements
Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a documentation error (missing warnings) rather than a direct physical defect, fitting the Moderate severity criteria for labeling/documentation issues.
Plain-English summary
Philips Electronics North America Corporation is recalling 94 units of the IntelliVue MX40 Patient Monitor, Model 867146, with software versions B.05, B.06, and B.06.5X. The recall was initiated because five warning statements are missing from the instructions for use.
The affected devices were distributed worldwide, including in the United States (all 50 states, DC, Guam, and Puerto Rico) and numerous international countries. The recall covers all devices of this specific model and software version.
Consumers and healthcare facilities should contact Philips Electronics North America Corporation for further instructions regarding the missing documentation.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 94
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)
- All devices.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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