Recall Z-1199-2019— GE Healthcare, LLC

Name: FDA recall Z-1199-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-15

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-03-15. It names one FDA 510(k) clearance: K111209. Product: Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.. Reason: There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-03-15
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K111209 — INTEGRATED INNOVA - S5I SYSTEM OPTIONGE Healthcare·cleared 2011-07-26

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 IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Reason for recall

There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.

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