Data Foundry

Medical device recalls 2015

Getinge 86 Series Washer/Disinfector with G1 control system software — Class III medical device recall Z-2419-2015

Terminated recall by Getinge Disinfection Ab, reported 2015-08-26, distributed in CA, CT, GA, IA, ID, MD, MI, MN…. Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote acces

Recall numberZ-2419-2015
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGetinge Disinfection Ab, Vaxjo, Sweden
Recall initiated2015-06-26
Classified2015-08-19
Reported by FDA2015-08-26
Terminated2018-05-23
DistributedCA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, WA
Quantity20 devices
Model numbers8666, 8668

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2419-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.