Recall Z-1009-2019— Olympus Corporation of the Americas

Name: FDA recall Z-1009-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-17

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2018-12-17, terminated 2020-11-18. It names one FDA 510(k) clearance: K100584. Product: Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.. Reason: The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Terminated: 2020-11-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K100584 — EVIS EXERAII 180 SYSTEMOlympus Medical Systems Corporation·cleared 2010-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

Reason for recall

The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.

Data sourced from openFDA. This site is unofficial and independent of the FDA.