EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus vide
FDA device recall Z-2807-2015 · posted 2015-09-22 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
- Action taken
- The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning instructions when the new brushes arrive on/about May 8, 2015. If you have question, contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, Monday-Friday between 7 AM EST - 8 PM EST. For additional information on this matter, contact V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or by email at laura.storms@olympus.com.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- FDT
- Quantity affected
- 6109
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
- Date initiated
- 2015-03-26
- Date posted
- 2015-09-22
- Date terminated
- 2017-02-01
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XTJF TYPE Q160VF1 (K080403) | Olympus Medical Systems Corporation | 2008-05-20 |