Recall Z-0584-2019— GE Healthcare, LLC

Name: FDA recall Z-0584-2019
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 4 FDA 510(k) clearances: K151063, K133576, K130584 and 1 more. Product: PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 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

4 on FDA's record

K151063 — Monitor B40Ge Medical Systems China Co., Ltd.·cleared 2015-12-15
K133576 — MONITOR B40Ge Medical Systems China Co., Ltd.·cleared 2014-02-21
K130584 — MONITOR B40Ge Medical Systems China Co., Ltd.·cleared 2013-06-26
K120598 — PROCARE MONITOR B40Ge Medical Systems China Co., Ltd.·cleared 2012-07-19

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 B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 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.