Device product
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
Z-1471-2020
Product summary
- Firm
- Verathon, Inc.
- Event
- Event 84329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 239 manuals
- Official record key
device-enforcement:Z-1471-2020
Official wording
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.
Code information: 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)
Distribution pattern: 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
Derived failure modes
-
Unknown
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.