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

FDA device recall Z-1142-2013 · posted 2013-04-18 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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

Action taken

A field action was initiated on October 21, 2011, and completed March 9, 2012, . The issue was corrected to all affected systems by applying the missing label onto the gantry. No recall letter was issued. For further questions please call (262) 513-4122.

Root cause

Labeling design

Status

Terminated

Product code

OWB

Quantity affected

48

Distribution

Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong

Date initiated

2011-10-21

Date posted

2013-04-18

Date terminated

2014-02-04

Location

Waukesha, WI

Related 510(k) clearances