Recall Z-1981-2015— GE Healthcare

Name: FDA recall Z-1981-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-29

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-05-29, terminated 2015-10-28. It names one FDA 510(k) clearance: K122457. Product: GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.. Reason: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery)..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Terminated: 2015-10-28
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 Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

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