Recall Z-0292-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 45356
| Date | Sep 19, 2016 |
| Status | Terminated |
| Reason | Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX |
| Root cause | Software design |
| Action | The firm, Philips Healthcare, sent a "Field Safety Notice (FSN)" dated 9/14/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make sure that the MX40 Patient Wearable Monitor local configuration setting 'Alarms On' is configured to its factory default until your software is upgraded; and follow the instructions listed in the letter. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade. If you need any further information or support con |
| Quantity | 1824 units |
| Distribution | Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zeala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113125 | INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems, Nov 17, 2011 |