Recall Z-0292-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of
| Date | Aug 23, 2017 |
| Status | Open, Classified |
| Reason | Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors |
| Root cause | Software design |
| Action | Philips sent an Urgent Medical Device Correction letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips will provide software update and is provding interim instructions for the operator. For questions contact your local Philips representative. |
| Quantity | 7071 |
| Distribution | Worldwide Distribution and US Nationwide |
| FDA record | Open on fda.gov |