Home / Recalls / Olympus Corporation of the Americas / Z-0119-2021

Z-0119-2021 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 28, 2020
Initiation Date
August 31, 2020
Termination Date
December 6, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
193 devices distributed in the U.S. 548 devices distributed globally.

Product Description

Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).

Reason for Recall

The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.

Distribution Pattern

US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.

Code Information

All lot codes..

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