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.
Recall
- Recall Number
- Z-2818-2015
- Event Number
- 72051
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- ODG
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 21, 2015
- Posted
- September 28, 2015
- Terminated
- May 8, 2017
- Address
- PO Box 610, 3500 Corporate Pkwy Center, Valley, PA, 18034-8229
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.
Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
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.
Nationwide Distribution
1014