Recall Z-0291-2017— Philips Electronics North America Corporation

Name: FDA recall Z-0291-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-19

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-09-19, terminated 2018-05-25. It names one FDA 510(k) clearance: K113125. Product: Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. 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: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX.

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Terminated: 2018-05-25
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

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. 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

Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX

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