FDA recall Z-1206-2024

Olympus Corporation of the Americas · Class II · device

Product

Colonoscope, Model Number CF-HQ190I.

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-01-11
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1206-2024