Home / Recalls / Philips North America Llc / Z-0545-2021

Z-0545-2021 Class II Terminated

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
December 16, 2020
Initiation Date
November 18, 2020
Termination Date
July 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units OUS

Product Description

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 environment.

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 Pattern

Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.

Code Information

Serial Numbers: DE73602213 DE73602577 UDI: (01)00884838000278(21)DE73602213 (01)00884838000278(21)DE73602577

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