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).
- 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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