Z-2807-2015 Class II Terminated
FDA device recall Z-2807-2015 was initiated by Olympus America Inc. on March 26, 2015 and is designated Class II. 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. The recall status is terminated (terminated February 1, 2017). Affected quantity: 6109.
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2015
- Initiation Date
- March 26, 2015
- Termination Date
- February 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6109
Product Description
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
Code Information
Model: TJF-Q180V, all sold units