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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliVue MP2

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  Class 2 Device Recall Philips IntelliVue MP2 see related information
Date Initiated by Firm November 18, 2020
Create Date December 08, 2020
Recall Status1 Terminated 3 on July 22, 2021
Recall Number Z-0545-2021
Recall Event ID 86848
510(K)Number K083517  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product 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.
Code Information Serial Numbers: DE73602213 DE73602577  UDI:  (01)00884838000278(21)DE73602213 (01)00884838000278(21)DE73602577  
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action Philips North America issued Customer notifications on 11/18/2020 to US customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Philips is asking users to follow the Action to be Taken by Customer/User section of the FSN: Affected products may continue to be used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the Speaker Malfunct. INOP at power-up. If you experience this INOP or there is no sound from your X2 / MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative Philips representative or Philips Customer Support at 1-800-722-9377 Please complete the attached Reply Card and return it to Philips as soon as possible. Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative will contact you to arrange for the replacement of the speaker assembly in the listed affected devices.
Quantity in Commerce 2 units OUS
Distribution Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
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