Recall Z-2476-2020— Verathon, Inc.

Name: FDA recall Z-2476-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-05

Class I · Terminated

Class I FDA medical device recall by Verathon, Inc., initiated 2020-06-05, terminated 2024-04-22. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm: Verathon, Inc.
Classification: Class I
Status: Terminated
Initiated: 2020-06-05
Terminated: 2024-04-22
Firm location: Bothell, WA, United States

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.

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