Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure
Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.
What this means for you
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 safety feature failure (alarm not sounding) which poses a risk of harm to patients, but the source text does not report any 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 Philips IntelliVue Measurement Module X1 (Model M3001A). The recall affects units with Software Revision K.21.54 or L.00.96. These devices were distributed nationwide and in numerous countries worldwide.
The recall was initiated because 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 an audible alert for specific ECG conditions.
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 these are medical devices typically managed by institutional procurement or biomedical engineering departments.
The recalled product
- Product
- Philips IntelliVue Measurement Module X1 Model: M3001A
- 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.
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