Philips IntelliVue MX40 Wearable Patient Monitor Alarm Failure Recall
Philips is recalling IntelliVue MX40 monitors because alarms may not resume after being paused, potentially delaying clinical response.
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 high-risk medical device where a failure to alarm poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Philips Medical Systems, Inc. is recalling the IntelliVue MX40 Wearable Patient Monitor (part numbers 865350, 865352) when used with the Philips IntelliVue Information Center iX (PIIC iX). The recall involves approximately 42,600 units distributed in the United States and numerous foreign countries.
The recall is issued because the device may not resume alarming when alarms are paused and the pause timer ends. This defect could prevent the monitor from alerting healthcare providers to patient status changes, potentially delaying necessary clinical interventions.
Healthcare facilities should identify affected units by checking for serial numbers within the ranges 00700001 - US01443745 and US014Z1301 - US014Z1431 that have the MX40 interfaces. Affected units should be removed from service and returned to Philips for evaluation or repair.
The recalled product
- Product
- IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
- Affected units
- 42,600
Distribution
Distributed nationwide across the United States.
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