FDA-Device2021-05-05Class III

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

Boston Scientific Corporation
Hazard

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

Sold states
US Nationwide distribution in the states of CA, FL, NJ.
Affected count
3 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2021

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