FDAnews Device Daily Bulletin

TGA Pulls Philips’ IntelliVue MX40 Patient Monitors

May 26, 2017

Australia’s Therapeutic Goods Administration suspended Philips’ license for its IntelliVue MX40 wearable patient monitor after repeated speaker failures.

The monitors are worn by patients in hospitals to record and generate alarms for heart rate, oxygen saturation and other functions. The agency determined that the device could fail in certain situations, particularly when it is not connected to the main hub.

The company will not be able to market the product in Australia until the problem is fixed. But the agency recommended not removing monitors that have not been problematic. 

The device is manufactured by Philips Medical Systems in the U.S. and is supplied to Philips Australia and New Zealand.

View today's stories