Recall Z-2476-2020 ยท CCW Laryngoscope, Rigid
Verathon, Inc.
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.
| Date | Jul 10, 2020 (initiated Jun 5, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 06/05/20, Field Safety Notice/ URGENT:MEDICAL DEVICE RECALL notices were sent to customers. Customers were asked to do the following: - Review the information contained within this Field Safety Notice with all staff members who should be aware of the contents of the Field Safety Notice. - Discontinue use of all affected cables. - When replacements are received, destroy or return all affected cables in your possession. - Complete and return the recall response form. Customers with additional questions are encouraged to contact Customer Care agent support Monday through Friday from 6:00a |
| Quantity | 437 |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.