18

Apr

2019

Recall – X-ray system loses imaging function under certain conditions

recall, softwareerror

0

Company: GE Healthcare, LLC
Date of Enforcement Report: 4/18/2019
Class II:

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.

Recall Number: Z-1199-2019

Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Recall Number: Z-1200-2019

Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

Recall Number: Z-1201-2019

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/MANUFACTURER

GE Healthcare, LLC on 3/15/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION

US Nationwide and International

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