FDA Enforcement
Class III
Terminated
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.
Recall: Z-2419-2015
·
Reported August 26, 2015
Enforcement
- Recall Number
- Z-2419-2015
- Event ID
- 71777
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Getinge Disinfection Ab
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 26, 2015
- Initiation Date
- June 26, 2015
- Classification Date
- August 19, 2015
- Termination Date
- May 23, 2018
- Address
- Ljungadalsgatan 11, Vaxjo, N/A, Sweden
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
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Code Info
Software versions up to and including 1.5.1.
Distribution
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
Quantity
20 devices