Z-2419-2015 Class III Terminated
FDA device recall Z-2419-2015 was initiated by Getinge Disinfection Ab on June 26, 2015 and is designated Class III. 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. The recall status is terminated (terminated May 23, 2018). Affected quantity: 20 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2015
- Initiation Date
- June 26, 2015
- Termination Date
- May 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 devices
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.
Distribution Pattern
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
Code Information
Software versions up to and including 1.5.1.