FDA recall Z-1492-2021

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA, FL, NJ.

Key facts

Status

Terminated

Initiation date

2021-03-16

Report date

2021-05-05

Termination date

2022-05-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

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