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FDA (Device enforcement)Recalled 2020-11-18closedclass ii

Philips North America Llc: Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of

Is my product affected?

Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital envi

  • UPC 00884838000278

Check against the official notice below — it lists the full affected range.

What happened

Philips North America LLC has recalled Philips IntelliVue MP2 Patient Monitors due to a potential speaker failure issue. The speakers on these monitors may fail, which can be identified either by a "Speaker Malfunct. INOP" message displayed on the screen or by the absence of audible sound. This failure could result in delayed treatment of patients since the monitors are designed to generate alarms for multiple physiological parameters. The recall affects 2 units located outside the United States, with worldwide distribution reported in South Dakota and internationally in China, England, Germany, Hong Kong, and Portugal.

The affected monitors have specific serial numbers: DE73602213 and DE73602577. The source document does not specify what remedy consumers or healthcare facilities should pursue regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

Details from the source

Reason for recall: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient. Distribution: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal. Quantity: 2 units OUS Lot/code info: Serial Numbers: DE73602213 DE73602577 UDI: (01)00884838000278(21)DE73602213 (01)00884838000278(21)DE73602577

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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