Recall Z-0583-2019— GE Healthcare, LLC

Name: FDA recall Z-0583-2019
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: K122253. Product: PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 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 intrahospital 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

K122253 — PROCARE MONITOR B20Ge Medical Systems China Co., Ltd.·cleared 2013-03-22

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

PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 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 intrahospital 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.