FDA-Device2016-10-26Class II
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Olympus Corporation of the Americas
Hazard
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
Sold states
Distributed to: AK,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,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
Affected count
2, 686 units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0138-2017Don't want to check this manually?
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