Recall Z-1229-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
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 medica
| Date | Jan 17, 2017 |
| Status | Terminated |
| Reason | The monitor may not alarm appropriately for a pediatric or neonatal patient. |
| Root cause | Unknown/Undetermined by firm |
| Action | Philips sent each known affected customer an Urgent Medical Device Correction Notification/Field Safety Notice dated December 2016 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a replacement MRx unit, free of charge, for all units affected by this issue. When the replacement unit arrives, please use the return shipping label and packaging provided with the replacement MRx unit to return the affect |
| Quantity | 156 devices, there is no US distribution |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160951 | Philips Efficia CMS200 Central Monitoring System Philips Medical Systems, May 5, 2016 |