Recall Z-1706-2016— GE Medical Systems, LLC

Name: FDA recall Z-1706-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2016-04-15, terminated 2016-11-22. It names one FDA 510(k) clearance: K113403. Product: GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.. Reason: Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Terminated: 2016-11-22
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K113403 — GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEMGE Medical Systems SCS·cleared 2012-02-14

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, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.

Reason for recall

Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.

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