FDA Device recall Z-2419-2015
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668
- FDA Device
- Class III
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class III recall of Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668 by Getinge Disinfection Ab, citing getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2419-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-06-26 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Getinge Disinfection Ab |
| Distribution | CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, WA |
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.
Identifiers
| code_info | Software versions up to and including 1.5.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2419-2015%22
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