Company: Philips Electronics North America Corporation
Date of Enforcement Report 3/1/2017
Class lI:
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
Recall Number Z-1229-2017
REASON
The monitor may not alarm appropriately for a pediatric or neonatal patient.
RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 1/17/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
158
DISTRIBUTION
Internationally
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