FDA-Device2015-08-26Class III
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Getinge Disinfection Ab
Hazard
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Sold states
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
Affected count
20 devices
Manufactured in
Ljungadalsgatan 11, Vaxjo, Sweden
Products
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2419-2015Don't want to check this manually?
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