Philips recalled 1,913,441 IntelliVue MX600 patient monitors distributed worldwide after reports that the devices did not alarm. The defect could prevent alarms that alert clinicians to patient distress. Hospitals and clinicians should stop using the devices immediately and follow the recall instructions from Philips North America LLC.
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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IntelliVue MX600 is a patient monitoring system used in clinical settings to track vital signs. It is designed to alert clinicians to deteriorating patient conditions.
The defect can cause monitors to fail to emit alarms when a patient’s condition requires attention, potentially delaying intervention.
This recall is not described as part of a broader industry pattern.
Hospitals and clinicians must stop using these devices and await replacement or repair instructions to ensure patient safety.
On device labels, packaging, and hospital asset records; recall communications from Philips.
Remedies are handled by Philips through replacement or repair channels; specific timelines are not provided in the notice.
Keep copies of the recall notice, all correspondence with Philips, and records of the affected device identifiers.
Model numbers: Product Number 865242; UDI-DI: 00884838029095; All Serial Nos. affected; Distribution: Worldwide including US nationwide and many countries; Sold quantities or price: Not disclosed.
No injuries or incidents have been reported.
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