Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue
Philips is recalling IntelliVue MX40 patient monitors because a configuration setting may disable ECG alarms. The issue affects 9,804 units distributed in the US and 35 other countries.
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 defect that disables critical safety alarms (ECG), creating 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 9,804 units of the IntelliVue MX40 Patient Monitor. The recall involves specific software revisions (B.05.28, B.05.29, and B.05.32) and exchange parts. The devices are intended for monitoring physiological parameters of adults and pediatrics in hospital environments and during transport.
The recall is due to a configuration setting that disables the generation and delivery of ECG alarms to the PIIC iX. This defect could prevent healthcare professionals from receiving necessary alarm notifications regarding patient physiological parameters.
The affected units were distributed nationwide in the United States and in 35 other countries, including Canada, the United Kingdom, Germany, and Japan. Healthcare facilities should contact Philips to resolve the issue and ensure proper alarm functionality.
The recalled product
- Product
- Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated f
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 9,804
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 (3)
- SW Revisions: B.05.28
- B.05.29
- and B.05.32
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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