Recall Z-2142-2018— Philips Electronics North America Corporation

Name: FDA recall Z-2142-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-30

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-04-30, terminated 2019-10-04. It names one FDA 510(k) clearance: K113125. Product: IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351. Reason: Five warning statements are missing from the instructions for use..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-04-30
Terminated: 2019-10-04
Firm location: Andover, 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, Software Versions B.05, B.06, B.06.5X, Model 865351

Reason for recall

Five warning statements are missing from the instructions for use.

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