Recall Z-2818-2015 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Olympus Corporation of the Americas
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.
| Date | Sep 28, 2015 (initiated Aug 21, 2015) |
| Status | Terminated |
| Reason | Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope |
| Root cause | Device Design |
| 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. |
| Quantity | 1014 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE Olympus Medical Systems Corporation, Jun 17, 2010 |