Recall Z-0453-2015— GE Healthcare, LLC

Name: FDA recall Z-0453-2015
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: K052412. Product: Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.. 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

K052412 — INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQGE Healthcare·cleared 2005-09-16

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

Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.

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.