The Recall Desk
LowFDA (Devices)·Z-2419-2015·Announced 2015-08-26

Getinge 86 Series Washer/Disinfector Recalled for Remote Access Vulnerability

Getinge Disinfection AB is recalling 20 Model 8666 and 8668 washer/disinfectors due to a potential for unauthenticated remote network access.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a cybersecurity vulnerability with no reported physical harm or illness.

Plain-English summary

Getinge Disinfection AB has initiated a Field Correction for the Getinge 86 Series Washer/Disinfector with G1 control system software, specifically Models 8666 and 8668. The recall involves 20 devices distributed in California, Connecticut, Georgia, Iowa, Idaho, Maryland, Michigan, Minnesota, New York, Pennsylvania, Texas, and Washington. The affected units are those with software versions up to and including 1.5.1.

The recall is due to the potential for unauthenticated remote access to the product over the network. This is a cybersecurity issue rather than a physical defect or contamination hazard. The devices are used in healthcare facilities and laboratories for the decontamination of reusable items such as instruments, utensils, anesthesia sets, and glassware.

Healthcare facilities and laboratories that use these specific models should verify their software versions and contact Getinge Disinfection AB for instructions on the field correction. No illnesses or injuries have been reported in connection with this recall.

The recalled product

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.
Affected units
20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software versions up to and including 1.5.1.

Distribution

Distributed in 12 states: