FDA recall Z-1671-2021

Philips North America Llc · Class II · device

Product

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Reason for recall

Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

Distribution

Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.

Key facts

Status: Terminated
Initiation date: 2021-02-02
Report date: 2021-06-02
Termination date: 2022-09-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1671-2021