Recall Z-1318-2013— GE Healthcare, LLC

Name: FDA recall Z-1318-2013
Creator: U.S. Food and Drug Administration
Published: 2011-12-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-12-20, terminated 2014-03-13. It names 5 FDA 510(k) clearances: K061163, K052412, K052157 and 2 more. Product: GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.. Reason: While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-12-20
Terminated: 2014-03-13
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

K061163 — INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPTGe Medical Systems, LLC·cleared 2006-06-07
K052412 — INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQGE Healthcare·cleared 2005-09-16
K052157 — INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQGe Medical Systems, LLC·cleared 2005-08-25
K050489 — INNOVA 2100Ge Medical Systems, LLC·cleared 2005-03-11
K042053 — INNOVA 4100, INNOVA 3100Ge Medical Systems, Inc.·cleared 2004-08-26

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 Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.

Reason for recall

While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.

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