Z-2476-2020 Class I Terminated

Recalled by Verathon, Inc. — Bothell, WA

Recall Details

Product Type
Devices
Report Date
July 15, 2020
Initiation Date
June 5, 2020
Termination Date
April 22, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
437

Product Description

GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction with ancillary equipment, for endoscopic procedures.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.

Code Information

All serial numbers