Recall Z-2818-2015— Olympus Corporation of the Americas

Name: FDA recall Z-2818-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-21

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2015-08-21, terminated 2017-05-08. It names one FDA 510(k) clearance: K093395. Product: EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.. Reason: Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2015-08-21
Terminated: 2017-05-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K093395 — OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPEOlympus Medical Systems Corporation·cleared 2010-06-17

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

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

Reason for recall

Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope

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