Recall Z-0811-2016— Verathon, Inc.

Class II FDA medical device recall by Verathon, Inc., initiated 2015-04-13, terminated 2016-10-26. FDA's recall record names no specific 510(k) clearance for this event. Product: GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.. Reason: Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product..

Recalling firm

Verathon, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-04-13

Terminated

2016-10-26

Firm location

Bothell, WA, United States

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