Recall Z-0747-2014— GE Healthcare, LLC

Name: FDA recall Z-0747-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-27

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-11-27, terminated 2016-09-07. It names one FDA 510(k) clearance: K071073. Product: GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.. Reason: GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-11-27
Terminated: 2016-09-07
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K071073 — SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGe Medical Systems Information Technologies·cleared 2007-05-11

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 Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.

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