Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue
Philips is recalling 1,824 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms.
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 where a failure to generate alarms poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Philips Electronics North America Corporation is recalling 1,824 units of the IntelliVue MX40 Patient Monitor. The recall affects devices with software revisions B.05.28, B.05.29, and B.05.32 that were distributed worldwide, excluding the United States.
The recall is due to a configuration setting that disables the generation and delivery of ECG alarms to the PIIC iX. This issue may prevent the monitor from properly alerting healthcare professionals to specific patient physiological parameters.
Healthcare professionals should contact Philips to arrange for the necessary corrective actions or exchanges for the affected devices.
The recalled product
- Product
- Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 4535
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,824
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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