Recall Z-1035-2016 ยท CCW Laryngoscope, Rigid
Verathon, Inc.
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Par
| Date | Mar 11, 2016 (initiated Jan 29, 2016) |
| Status | Terminated |
| Reason | The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal. |
| Root cause | Process control |
| Action | The firm, Verathon, began mailing the "URGENT: MEDICAL DEVICE RECALL" GLIDESCOPE VIDEO LARYNGOSCOPE TITANIUM SINGLE-USE BLADES letter to their consignees on January 29, 2016. The letter describes the product, problem and actions to be taken. Verathon will instruct the company's foreign distributors to communicate the Customer Recall Letter to their international customers. Verathon has contracted with a business services company, Stericycle, to coordinate the initial consignee communications in the United States, Australia and Canada. Stericycle will send the Customer Recall Letters, and con |
| Quantity | 7733 units (6377 units in the US and 1356 units International) |
| Distribution | Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.