Philips M3015A Microstream CO2 Extension Recall for Incompatibility
Philips is recalling M3015A Microstream CO2 Extensions because they are incompatible with IntelliVue X3 and MMX monitors, which may cause a loss of monitoring.
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 where a defect (loss of monitoring) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling the M3015A Microstream CO2 Extension (Model No. 862393). This device is used with the IntelliVue X3 Patient Monitor (Model No. 867030) or the IntelliVue MMX Multi-Measurement Module (Model No. 867036). The recall involves 46,597 units distributed nationwide and in numerous foreign countries.
The affected extensions are incompatible with the specified host monitors. If connected to an IntelliVue X3 or MMX monitor, communication between the devices could be disrupted. This disruption results in a loss of monitoring on the host monitor.
Affected units can be identified by the serial number prefix DE435xxxxx (first five digits). Users should check their device serial numbers to determine if they are affected.
The recalled product
- Product
- Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 46,597
Distribution
Distributed nationwide across the United States.
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