Recall Z-2419-2015— Getinge Disinfection Ab
Class III · Terminated
Class III FDA medical device recall by Getinge Disinfection Ab, initiated 2015-06-26, terminated 2018-05-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network..
- Recalling firm
- Getinge Disinfection Ab
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-06-26
- Terminated
- 2018-05-23
- Firm location
- Vaxjo, Sweden
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.