EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound
FDA device recall Z-2818-2015 · posted 2015-09-28 · Terminated
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope
- Action taken
- 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
- Status
- Terminated
- Product code
- ODG
- Quantity affected
- 1014
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-08-21
- Date posted
- 2015-09-28
- Date terminated
- 2017-05-08
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE (K093395) | Olympus Medical Systems Corporation | 2010-06-17 |