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Recall Observatory FDA recall evidence

Device product

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.

Z-2419-2015

June 26, 2015

Class III

Product summary

Firm
Getinge Disinfection Ab
Event
Event 71777
Status
Terminated
Classification
Class III
Quantity
20 devices
Official record key
device-enforcement:Z-2419-2015

Official wording

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

Code information: Software versions up to and including 1.5.1.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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