Z-2419-2015 Class III Terminated

Recalled by Getinge Disinfection Ab — Vaxjo

Recall Details

Product Type
Devices
Report Date
August 26, 2015
Initiation Date
June 26, 2015
Termination Date
May 23, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 devices

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Software versions up to and including 1.5.1.