Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System

FDA device recall Z-0617-2010 · posted 2010-01-13 · Terminated

Recall details

Recalling firm: GE Medical Systems, LLC
Reason for recall: Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient
Action taken: Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Root cause: Device Design
Status: Terminated
Product code: MQB
Quantity affected: 374
Distribution: Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBL
Date initiated: 2009-12-22
Date posted: 2010-01-13
Date terminated: 2015-11-13
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT (K061163)	Ge Medical Systems, LLC	2006-06-07
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ (K052412)	GE Healthcare	2005-09-16
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157)	Ge Medical Systems, LLC	2005-08-25
INNOVA 2100 (K050489)	Ge Medical Systems, LLC	2005-03-11