Philips IntelliVue MX40 Patient Monitor Recalled for Missing Warning Statements
Philips is recalling 7,178 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) rather than a direct physical defect or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Electronics North America Corporation is recalling 7,178 units of the IntelliVue MX40 Patient Monitor, Model 865351, with software versions B.05, B.06, and B.06.5X. The recall is due to five warning statements being missing from the instructions for use.
The affected devices were distributed worldwide, including in the United States and its territories, as well as in numerous international countries. The recall covers all devices released since the B.05 software version in March 2016 with a prefix date code of US096 or later.
Healthcare facilities and users should contact Philips for instructions on how to obtain the corrected instructions for use. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 7,178
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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