FDA recall Z-1034-2022

Olympus Corporation of the Americas · Class II · device

Product

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

Reason for recall

GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2022-03-18
Report date
2022-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1034-2022