FDA Device recall Z-1229-2017
Philips Efficia CMS200 Central Monitoring System
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of Philips Efficia CMS200 Central Monitoring System by Philips Electronics North America, citing the monitor may not alarm appropriately for a pediatric or neonatal patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1229-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-17 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
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
Reason
The monitor may not alarm appropriately for a pediatric or neonatal patient.
Identifiers
| code_info | US11600058 US11600059 US11600060 US11600061 US11600062 US11600063 US21600064 US21600065 US21600066 US21600067…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 US81 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1229-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.