Recall Z-1746-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1746-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-22

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-05-22, terminated 2018-05-16. It names 2 FDA 510(k) clearances: K113125, K103646. Product: IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352. Reason: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-22
Terminated: 2018-05-16
Firm location: Andover, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K113125 — INTELLIVUE MX40 PATIENT MONITORPhilips Medical Systems·cleared 2011-11-17
K103646 — INTELLIVUE MX40 PATIENT MONITORPhillips Medical Systems·cleared 2011-01-07

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 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352

Reason for recall

IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.

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