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Recall Observatory FDA recall evidence

Device product

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

Z-1471-2020

March 31, 2019

Class II

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

    reason.no_named_rule · v1.0.0

    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.

Field note

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