FDA recall Z-1275-2022

Olympus Corporation of the Americas · Class II · device

Product

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

Reason for recall

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

Distribution

US Nationwide distribution in the states of AL, FL, NC, NY.

Key facts

Status: Ongoing
Initiation date: 2022-04-22
Report date: 2022-06-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2022