FDA Medical Device Recalls (openFDA)
Verathon, Inc.: GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
- Recall number
- Z-1471-2020
- Recalling firm
- Verathon, Inc.
- Product
- GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
- Status
- Terminated
- Initiated
- 2019-03-31
- Posted
- not on file
- Terminated
- 2021-12-14
- Reason
- A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.
- Root cause
- Error in labeling
- Action
- 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
- Quantity
- 239 manuals
- Distribution
- US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada
- Lot, serial or model codes
- GlideScope Video Laryngoscope Operation and Maintenance Manual Catalog #: 0900-4940 Product can be further identified as In-Service USB 0901-0197 Affected Revision Rev. 00 distributed January 1, 2019 February 28, 2019 GlideScope Video Laryngoscope Product Serial Numbers are included in Appendix A: Domestic and Foreign Consignee List (in Associated Documents)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3022472
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28