GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03

On 03/31/2019 the firm communicated a "Field Safety Notice Medical Device Recall" letter to customers via FedEx informing them the firm has identified that the disinfection levels outlined in Table 9 (Table 9. System Risk Classification) on page 23 of the Operations & Maintenance Manual (OMM) incorrectly indicates (X in the table cell) that low level disinfection is the minimum disinfection level required for the reusable Titanium video laryngoscope. The correct reference should be an X in the table cell indicating that high-level disinfection is required. The error in Table 9 contradicts the other references and warnings in the OMM that correctly state The reusable Titanium video laryngoscope is considered a semicritical device intended to contact the airway. It must be thoroughly cleaned and undergo high-level disinfection after each use (pages 6, 21, and 34 of the OMM). Customers are instructed to: 1) Determine whether their facility currently has a copy of the In-Service USB (0901-0197) or the GlideScope Video Laryngoscopes Operations and Maintenance Manual 0900-4940 Rev.00 (OMM). If so, dispose of the In-Service USB as well as any printed or saved copies of the OMM. 2) Download and retain the updated GlideScope Video Laryngoscopes Operations and Maintenance Manual 0900-4940 Rev. 01 from the Product Documentation site: https://www.verathon.com/productdocumentation/ 3) Review the disinfection of any reusable Titanium video laryngoscopes completed from January 01, 2019 - February 28, 2019 to ensure that high-level disinfection was completed. High level disinfect any units that were or may have been processed using low-level disinfection. 4) Fill out the attached Recall Response Form and return it by email to CSNotifications@verathon.com. Some facilities may not currently have copies of the In-Service USB (0901-0197) or the OMM subject to this Field Safety Notice (e.g., because they did not retain the In-Service USB or print or save a copy