Recall Z-1616-2013— GE Healthcare, LLC

Name: FDA recall Z-1616-2013
Creator: U.S. Food and Drug Administration
Published: 2011-05-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-05-16, terminated 2014-03-13. It names 5 FDA 510(k) clearances: K061163, K052412, K052157 and 2 more. Product: GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.. Reason: GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-05-16
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
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 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.

Reason for recall

GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.

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