Philips IntelliVue MX40 Patient Monitor Recalled for Manufacturing Defects
Philips is recalling three IntelliVue MX40 patient monitors because manufacturing process failures may have resulted in defective devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential defect that could impact patient safety, but the source text does not report any specific injuries, illnesses, or FDA Class I classification, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling three units of the IntelliVue MX40 Patient Monitor (Model Numbers 865350 and 865352, Software Version B.06.59). The recall was initiated because manufacturing failed to follow required process steps, resulting in the distribution of potentially defective devices.
The affected units were distributed worldwide, specifically in the United States (Indiana and Minnesota) and Italy. The devices are intended for monitoring and recording physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Hospitals and healthcare facilities should identify the affected units by checking the serial numbers US09699788, US156J6219, and US156J3658. Affected facilities should contact Philips for instructions on how to proceed with the recall.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and…
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 3
Distribution
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