FDAFDA · Food and drugs·Recall number Z-2476-2020
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.
Published July 15, 2020 · Recall initiated: June 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Verathon, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.
- Lot
- All serial numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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