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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.

FDA Recall Z-2419-2015 · Posted 2015-08-25

Recalling FirmGetinge Disinfection Ab
Recall StatusTerminated
Product CodeMEC
Date Initiated2015-06-26
Date Terminated2018-05-23
Product Quantity20 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.

Firm Action

Getinge Disinfection AB has initiated a Field Correction due to unauthenticated remote access to the product over the network.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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