Recall Z-0966-2015— GE Healthcare

Name: FDA recall Z-0966-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-10

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2014-12-10, terminated 2015-06-01. It names 2 FDA 510(k) clearances: K133278, K113403. Product: GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.. Reason: Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2014-12-10
Terminated: 2015-06-01
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K133278 — DISCOVERY IGS 740GE Medical Systems SCS·cleared 2014-04-24
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 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

Reason for recall

Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.

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