Recall Z-0586-2019— GE Healthcare, LLC

Name: FDA recall Z-0586-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-11

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-09-11. It names one FDA 510(k) clearance: K143676. Product: B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.. Reason: Patient monitors may restart due to network overload caused by network configuration..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-09-11
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K143676 — B40i Patient MonitorGE Healthcare Finland Oy·cleared 2015-07-31

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

B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Reason for recall

Patient monitors may restart due to network overload caused by network configuration.

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