FDA-Device2016-07-13Class II
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
Custom Ultrasonics, Inc.
Hazard
To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
Sold states
Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.
Affected count
2,345 units
Manufactured in
144 Railroad Dr, N/A, Ivyland, PA, United States
Products
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2130-2016Don't want to check this manually?
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