Getinge Disinfection Ab recalls Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare…

Recall date

June 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2419-2015

FDA classification

Class III

Brand / firm

Getinge Disinfection Ab

Sold / distributed

Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.

Why it was recalled

Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.