Verathon

Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.

Due to a change in handle material and process, probe handle may crack.

When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss of live image/blank screen, no cameras connected monitor warning, may present risk to patients, in which time to intubation is more critical.

A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.

Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).

The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).

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.

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.

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.

Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.