Recall Z-0648-2014— GE Healthcare, LLC

Name: FDA recall Z-0648-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-12-16, terminated 2016-04-19. It names one FDA 510(k) clearance: K071073. Product: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module). Reason: GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-12-16
Terminated: 2016-04-19
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

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

Reason for recall

GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.

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