Philips North America LLC is recalling 1,913,441 IntelliVue MP5 patient monitors sold to hospitals worldwide. The devices may fail to alarm, delaying detection of patient distress. Hospitals and clinicians should stop using the monitors immediately and follow Philips recall instructions.
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 MP5 is a patient monitoring system used in clinical settings to track vital signs. It is deployed in hospitals to support continuous patient assessment and clinical decision making.
If the monitor fails to alarm, clinical staff may not be alerted promptly to patient deterioration. This can delay life-saving interventions in critical care situations.
This recall is not described as part of a broader industry pattern in the notification.
Hospitals must immediately implement the recall, stop using affected devices, and rely on alternative monitors or procedures to maintain patient safety while arrangements for replacement or refunds are completed.
Find model numbers and UDI on the device label, packaging, and in the recall notice. Detailed instructions are on the FDA enforcement page linked in the notice.
Refund or replacement processing may take several weeks. Hospitals should coordinate with Philips for interim safety protocols.
Keep the recall letter, incident logs, and replacement or refund correspondence. Photograph labels and serial numbers for records.
Model numbers: M8105A. UDI-DI: 00884838000230. All Serial No. Distribution: Worldwide. Sold to hospitals and healthcare facilities. Sold from unknown date. Price: Unknown.
No injuries or incidents have been reported.
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