Z-2419-2015Class III

Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in...

Name: Z-2419-2015 Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in...
Creator: Getinge Disinfection Ab
Published: 2015-06-26
License: https://open.fda.gov/license/

Getinge Disinfection AB / initiated 2015-06-26 / Terminated / root cause: software

FDA source

Getinge Disinfection Ab began a recall of Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where... on 2015-06-26. FDA classified it as Class III and gives the reason as "Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2419-2015
Classification: Class III
Status: Terminated
Initiated: 2015-06-26
Posted: 2015-08-25
Terminated: 2018-05-23
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.
Product code: MEC Disinfector, Medical Devices
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.
Root cause tag: software
FDA 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 in commerce: 20 devices
Distribution: Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
Product codes and lots: Software versions up to and including 1.5.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2419-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2419-2015	Class III	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)