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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Efficia

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  Class 2 Device Recall Philips Efficia see related information
Date Initiated by Firm January 17, 2017
Create Date February 22, 2017
Recall Status1 Terminated 3 on October 10, 2019
Recall Number Z-1229-2017
Recall Event ID 76274
510(K)Number K160951  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Philips Efficia CMS200 Central Monitoring System; 863352
The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals
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Recalling Firm/
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
The monitor may not alarm appropriately for a pediatric or neonatal patient.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Philips sent each known affected customer an Urgent Medical Device Correction Notification/Field Safety Notice dated December 2016 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a replacement MRx unit, free of charge, for all units affected by this issue. When the replacement unit arrives, please use the return shipping label and packaging provided with the replacement MRx unit to return the affected unit to Philips. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Option A: For any neonatal or pediatric patient, if the bedside monitor (without CO2) is connected to CMS200, do not place the bedside monitor in Standby when the patient is transported to a procedure. This will allow the alarms limits to work properly. Contact your service provider to determine the settings of your system and change if necessary. Option B: For any neonatal or pediatric patient, if the bedside monitor (without CO2) connected to CMS200 is placed in Standby when the patient is transported to a procedure. When the same patient returns to unit and is placed back on monitor, take the following steps: If clinician need disable or change alarm limit at CMS200 side, he/she need to discharge this patient at CMS200 side first, and admit same patient ID again. (Reference: Instruction for Use, Document Number 4535 645 61281, Page 89 of 199, section: Discharging a patient) This will allow the alarms limits to work properly. Contact your service provider to determine the settings of your system and change if necessary. For questions regarding this recall call 978-659-3000.
Quantity in Commerce 156 devices, there is no US distribution
Distribution Worldwide distribution including Austria Bangladesh Bulgaria Chile France Germany Hong Kong India Ireland Israel Italy Korea, Republic of Malaysia Myanmar Philippines Poland Portugal Saudi Arabia Thailand Turkey United Arab Emirates United Kingdom United Republic of Tanzania
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 = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS