Recall Z-1134-2012 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Healthcare Inc.
Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring, Patient Monitor , Arrhythmia detector and alarm (including ST -segment measurem
| Date | Mar 1, 2012 (initiated Feb 9, 2012) |
| Status | Terminated |
| Reason | Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor |
| Root cause | Software change control |
| Action | Philips Healthcare sent a Urgent Medical Device Correction letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips has recently received reports that, under certain circumstances, alarms announced at the patient monitor are not announced (either visual or audible) at the central station. This issue affects the following IntelliVue patient monitor models with SW rev. H.xx.xx MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8 |
| Quantity | 83,534 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of ALBANIA, ANGOLA, ANTILLES, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BYELORUSSIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110622 | INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Mar 31, 2011 |