Philips North America LLC recalled 1,913,441 IntelliVue MP80 patient monitors distributed worldwide to hospitals after reports the devices did not alarm. The defect could prevent alarms from sounding in critical patient situations. Healthcare facilities should stop using the monitors and follow recall instructions from the manufacturer.
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 MP80 is a patient monitor used in hospitals to track vital signs. It plays a role in alerting clinicians to patient deterioration.
If alarms fail to trigger, clinicians may miss critical signs of patient harm, delaying intervention.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals may need to replace or service affected monitors, which could affect monitoring continuity and staffing coordination.
Refer to the FDA enforcement page and Philips recall notices for submission and replacement instructions
4-8 weeks for replacement or service arrangements
Document device serials, purchase records, communications with Philips, and replacement status
Model numbers: M8008A. Sold worldwide to hospitals and healthcare providers. Sold from unknown date. Price unknown. Quantity recalled: 1,913,441 units. Countries distributed to: Worldwide.
No injuries or incidents have been reported.
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