Recall Z-1671-2021— Philips North America Llc

Name: FDA recall Z-1671-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-02

Class II · Terminated

Class II FDA medical device recall by Philips North America Llc, initiated 2021-02-02, terminated 2022-09-20. It names one FDA 510(k) clearance: K113125. 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: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Terminated
Initiated: 2021-02-02
Terminated: 2022-09-20
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113125 — INTELLIVUE MX40 PATIENT MONITORPhilips Medical Systems·cleared 2011-11-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.