Philips North America LLC recalled 1,913,441 IntelliVue MP40 patient monitors worldwide after reports the monitors did not alarm. The issue could prevent alerts to clinicians about patient deterioration. Stop using the device and follow the recall instructions from Philips or your healthcare provider immediately.
Potential issue where the IntelliVue monitors did not alarm.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
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The IntelliVue MP40 is a patient monitoring device used in clinical settings to track vital signs and clinical status of patients.
If the alarm function does not audible alert, clinicians may miss warning signs of patient deterioration, delaying response.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals must halt use of the affected monitors and coordinate with Philips for replacement or service to avoid potential delays in patient care.
Recall documentation and identifiers appear on the device label, packaging, and the FDA recall page
Remedy actions, including replacement or service, will be coordinated by Philips. Expect a process that may span weeks.
Save the recall notice, record device identifiers, and capture all correspondence with Philips for your records.
Model numbers: Product Number M8003A; UDI-DI: 00884838000162; All Serial No. sold worldwide. Sold in US nationwide and many other countries. Price: Not disclosed. Sold date: Not disclosed.
No injuries or incidents have been reported.
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