Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring s...
FDA Device Recall #Z-1229-2017 — Class II — January 17, 2017
Recall Summary
| Recall Number | Z-1229-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 17, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Electronics North America Corporation |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 156 devices, there is no US distribution |
Product Description
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
Reason for Recall
The monitor may not alarm appropriately for a pediatric or neonatal patient.
Distribution Pattern
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
Lot / Code Information
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 US61600123 US61600124 US61600125 US61600126 US61600129 US61600130 US61600131 US61600132 US61600133 US61600134 US61600135 US71600136 US71600137 US71600138 US71600139 US71600144 US71600145 US71600147 US71600148 US71600149 US71600150 US81600151 US81600152 US81600155 US81600156 US81600157 US81600158 US81600160 US81600161 US81600162 US81600163 US81600164 US91600165 US91600167 US91600171 US91600172 US91600173 US91600174 US91600175 US91600176 US91600177 USD1500045 USD1500046 USD1500047 USD1500048 USD1500049 USD1500050 USD1500051 USD1500052 USD1500054 USD1500056 USD1500057 USN1500002 USN1500003 USN1500004 USN1500005 USN1500006 USN1500007 USN1500008 USN1500009 USN1500010 USN1500011 USN1500015 USN1500016 USN1500017 USN1500018 USN1500019 USN1500028 USN1500029 USN1500030 USN1500031 USN1500032 USN1500034 USN1500035 USN1500036 USN1500037 USN1500038 USN1500039 USN1500040 USN1500041 USN1500042 USN1500043 USN1500044 USO1600182 USO1600183 USO1600184 USO1600185 USO1600186 USO1600187 USO1600188 USO1600189 USO1600190 USO1600191 USO1600192 USO1600193 USO1600196
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.