Recall Z-1142-2013— GE Healthcare, LLC

Name: FDA recall Z-1142-2013
Creator: U.S. Food and Drug Administration
Published: 2011-10-21

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-10-21, terminated 2014-02-04. It names 5 FDA 510(k) clearances: K052412, K052157, K050489 and 2 more. Product: GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.. Reason: As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-10-21
Terminated: 2014-02-04
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

5 on FDA's record

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
K033244 — DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTIONGe Medical Systems, Inc.·cleared 2003-10-16

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 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

Reason for recall

As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co

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