Philips Efficia CMS200 Central Monitoring System — Class II medical device recall Z-1229-2017
Terminated recall by Philips Electronics North America Corporation, reported 2017-03-01. The monitor may not alarm appropriately for a pediatric or neonatal patient.
| Recall number | Z-1229-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2017-01-17 |
| Classified | 2017-02-22 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2019-10-10 |
| Countries outside the US | AE, AT, BD, BG, CL, DE, FR, GB, HK, IE, IL, IN, IT, KR, MY, PH, PL, PT, SA, TH, TR |
| Quantity | 156 devices |
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 for recall
The monitor may not alarm appropriately for a pediatric or neonatal patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1229-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.