Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements
Philips is recalling 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, but the hazard is a documentation error (missing warning statements) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Philips Electronics North America Corporation is recalling the IntelliVue MX40 Patient Monitor, Model 865350, Software Versions B.05, B.06, and B.06.5X. The recall involves 25,499 units that were distributed worldwide, including the United States, its territories, and numerous international countries.
The reason for the recall is that five warning statements are missing from the instructions for use. The affected devices are those released since version B.05 in March 2016, identified by a prefix date code of US096 or later.
Healthcare facilities and users should contact Philips to determine if their devices are affected and to obtain the correct instructions for use.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 25,499
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 since release of B.05 (March 2016) prefix date code >/= US096
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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