FDA recall Z-2476-2020

Verathon, Inc. · Class I · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2020-06-05
Report date
2020-07-15
Termination date
2024-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2476-2020