Recall Z-0451-2015— GE Healthcare, LLC

Name: FDA recall Z-0451-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-04

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-09-04, terminated 2015-01-21. It names one FDA 510(k) clearance: K122457. Product: Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.. Reason: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-09-04
Terminated: 2015-01-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K122457 — GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONSGE Healthcare·cleared 2013-01-02

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

Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Reason for recall

Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.

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