Recall Z-2085-2014— GE Healthcare, LLC

Name: FDA recall Z-2085-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-13

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-06-13, terminated 2016-09-07. It names 5 FDA 510(k) clearances: K192239, K132523, K131223 and 2 more. Product: GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.. Reason: Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-06-13
Terminated: 2016-09-07
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K192239 — WavelinQ Plus EndoAVF SystemC.R. Bard, Inc.·cleared 2019-10-17
K132523 — MYOPERFUSIONToshibamedical Systems Corporation·cleared 2013-12-12
K131223 — CARESCAPE MONITOR B650GE Healthcare Finland Oy·cleared 2013-08-28
K131414 — CARESCAPE MONITOR B850GE Healthcare Finland Oy·cleared 2013-08-28
K092027 — CARESCAPE MONITOR B850Ge Medical Systems Information Technologies·cleared 2009-08-28

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

GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

Reason for recall

Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.

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