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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DSI
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