Recall Z-1035-2016— Verathon, Inc.

Class I FDA medical device recall by Verathon, Inc., initiated 2016-01-29, terminated 2017-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.. Reason: The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal..

Recalling firm

Verathon, Inc.

Classification

Class I

Status

Terminated

Initiated

2016-01-29

Terminated

2017-03-01

Firm location

Bothell, WA, United States

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