FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2419-2015
- Recalling firm
- Getinge Disinfection Ab
- 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.
- Status
- Terminated
- Initiated
- 2015-06-26
- Posted
- 2015-08-25
- Terminated
- 2018-05-23
- 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.
- Lot, serial or model codes
- Software versions up to and including 1.5.1.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 3000231474
- Firm city
- Vaxjo
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28