Recall Z-0414-2016— GE Medical Systems, LLC

Name: FDA recall Z-0414-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-13

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-11-13, terminated 2016-09-07. It names one FDA 510(k) clearance: K122457. Product: GE Healthcare Optima IGS 320. Product Usage: 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 non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.. Reason: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-13
Terminated: 2016-09-07
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

GE Healthcare Optima IGS 320. Product Usage: 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 non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.

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