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Olympus Corporation of the Americas recalls Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, li
Recalled October 28, 2020 · FDA recall Z-0119-2021 · Olympus Corporation of the Americas
Hazard
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. · FDA Class II
Units
193 devices distributed in the U.S. 548 devices distributed globally.
Sold at
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.
Description
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.
Product
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).
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →