RecallDepth

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.

This recall has been terminated (originally issued August 25, 2015).

Company
Getinge Disinfection Ab Ljungadalsgatan
Recall Initiated
June 26, 2015
Posted
August 25, 2015
Terminated
May 23, 2018
Recall Number
Z-2419-2015
Quantity
20 devices
Official Source
View on FDA website ↗

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

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

Lot / Code Info

Software versions up to and including 1.5.1.

Root Cause

Software Manufacturing/Software Deployment

Action Taken

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

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