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 adults, pediatrics, and neonates in a hospital environment.
This recall is currently active, issued August 23, 2017. It was issued by Philips Electronics North America Corporation.
- Recall Initiated
- August 23, 2017
- Recall Number
- Z-0292-2018
- Quantity
- 7071
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
Distribution
Worldwide Distribution and US Nationwide
Lot / Code Info
Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on Consignee list Catalog #: 862442 (M3001A), 866462 (M3001AL), 865039 (M3002A), 865040 (M8102A), 865024 (M8105A)
Root Cause
Software design
Action Taken
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.