Philips IntelliVue Module Measurement X2 Recall for ST Alarm Failure
Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG 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 critical alarm may fail to sound, posing 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 Electronics North America Corporation is recalling 13,300 units of the IntelliVue Module Measurement X2 (Model M3002A). The recall affects software revisions K.21.54 or L.00.96. The product was distributed worldwide, including in the United States and numerous international markets.
The recall is due to a defect where the ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor. This failure could prevent healthcare providers from receiving critical alerts regarding potential cardiac events.
Healthcare facilities and users should contact Philips for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as this is a medical device used in professional settings.
The recalled product
- Product
- Philips IntelliVue Module Measurement X2 Model: M3002A
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 13,300
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)
- Software Revision: K.21.54 or L.00.96
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- HighIntelliVue X2 measurement servers recalled over a potential failure to alarm
FDA (Devices) · 2025-12-10
- HighIntelliVue X3 measurement modules recalled over a potential failure to alarm
FDA (Devices) · 2025-12-10
- HighPhilips IntelliVue X2 Multi Measurement Server Speaker Failure Recall
FDA (Devices) · 2020-12-16
- HighPhilips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display
FDA (Devices) · 2018-01-03
- HighIntelliVue MP2 monitors recalled over a potential alarm activation issue
FDA (Devices) · 2025-12-10
- HighPhilips IntelliVue Monitors Recalled for NBP Measurement Stoppage
FDA (Devices) · 2014-10-29