Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Efficia CMS200 Central Monitoring System Recalled by Philips Electronics North America Corporation Due to The monitor may not alarm appropriately for a...

Date: January 17, 2017
Company: Philips Electronics North America Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Electronics North America Corporation directly.

Affected Products

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

Quantity: 156 devices, there is no US distribution

Why Was This Recalled?

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

Where Was This Sold?

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

About Philips Electronics North America Corporation

Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report