Recall Z-2419-2015 ยท MEC Disinfector, Medical Devices
Getinge Disinfection Ab
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.
| Date | Aug 25, 2015 (initiated Jun 26, 2015) |
| Status | Terminated |
| Reason | Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Getinge Disinfection AB has initiated a Field Correction due to unauthenticated remote access to the product over the network. |
| Quantity | 20 devices |
| Distribution | Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.