Reported Mar 1, 2017 · Terminated

Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for…

Philips Electronics North America Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • 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
Lot codes and dates
  • 156 of 156 codes

    • US11600058
    • US11600059
    • US11600060
    • US11600061
    • US11600062
    • US11600063
    • US21600064
    • US21600065
    • US21600066
    • US21600067
    • US21600068
    • US31600069
    • US31600071
    • US31600073
    • US31600074
    • US31600075
    • US31600077
    • US31600078
    • US31600079
    • US31600080
    • US31600081
    • US31600082
    • US41600084
    • US41600085
    • US41600086
    • US41600087
    • US41600088
    • US41600089
    • US41600090
    • US41600091
    • US41600092
    • US41600093
    • US41600094
    • US41600095
    • US41600096
    • US51600097
    • US51600098
    • US51600099
    • US51600100
    • US51600101
    • US51600102
    • US51600103
    • US51600105
    • US51600106
    • US51600107
    • US51600108
    • US51600109
    • US51600110
    • US51600111
    • US51600112
    • US51600113
    • US51600114
    • US61600115
    • US61600116
    • US61600117
    • US61600118
    • US61600119
    • US61600120
    • US61600121
    • US61600122
Amount recalled
156 devices, there is no US distribution

Why it was recalled

The monitor may not alarm appropriately for a pediatric or neonatal patient.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 10, 2019 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.