Philips IntelliVue MX40 Patient Monitor Recalled for ECG Alarm Configuration Issue
Philips is recalling 2,212 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms. Users should contact Philips for a software update.
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 is classified as FDA Class II and involves a risk-of-harm product (patient monitor) where the failure to generate alarms could lead to adverse health consequences, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 2,212 units of the IntelliVue MX40 Patient Monitor, specifically the 802.11a/b/g model (Product Number 865352). The recall affects software revisions B.05.28, B.05.29, and B.05.32. The devices were distributed worldwide, including the United States and numerous international locations such as Australia, Canada, China, Germany, Japan, and the United Kingdom.
The recall is due to a configuration setting that can disable the generation and delivery of ECG alarms to the PIIC iX. This issue may prevent the monitor from properly alerting healthcare professionals to critical patient physiological parameters. The devices are intended for use by health care professionals to monitor and record physiological parameters of adults and pediatrics in hospital environments and during transport.
Healthcare facilities and users should contact Philips to arrange for a software update or replacement. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 4535646153
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 2,212
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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