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Terminated

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.

FDA Recall Z-2818-2015 · Posted 2015-09-28

Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeODG
Date Initiated2015-08-21
Date Terminated2017-05-08
Product Quantity1014

Reason for Recall

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

Firm Action

Olympus sent an Urgent Device Safety Information letter dated August 2015, to all affected customers. Corrected instructions were provided with the letter and users were asked to begin implementing them immediately. Customers were asked to indicate on the enclosed questionnaire and fax the completed from to 484-896-7128. Customers with questions were instructed to call 484-896-5688.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093395OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPEOlympus Medical Systems Corporation · 2010-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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