Recall Z-0823-2013— GE Healthcare, LLC

Name: FDA recall Z-0823-2013
Creator: U.S. Food and Drug Administration
Published: 2011-09-30

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-09-30, terminated 2014-01-27. It names one FDA 510(k) clearance: K102239. Product: GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.. Reason: GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-09-30
Terminated: 2014-01-27
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K102239 — CARESCAPE MONITOR B650GE Healthcare Finland Oy·cleared 2010-10-18

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 B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Reason for recall

GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.

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