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
US11600058US11600059US11600060US11600061US11600062US11600063US21600064US21600065US21600066US21600067US21600068US31600069US31600071US31600073US31600074US31600075US31600077US31600078US31600079US31600080US31600081US31600082US41600084US41600085US41600086US41600087US41600088US41600089US41600090US41600091US41600092US41600093US41600094US41600095US41600096US51600097US51600098US51600099US51600100US51600101US51600102US51600103US51600105US51600106US51600107US51600108US51600109US51600110US51600111US51600112US51600113US51600114US61600115US61600116US61600117US61600118US61600119US61600120US61600121US61600122
- 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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