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U.S. Department of Health and Human Services

Class 3 Device Recall Getinge 86 Series with G1 control system software

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  Class 3 Device Recall Getinge 86 Series with G1 control system software see related information
Date Initiated by Firm June 26, 2015
Date Posted August 25, 2015
Recall Status1 Terminated 3 on May 23, 2018
Recall Number Z-2419-2015
Recall Event ID 71777
Product Classification Disinfector, medical devices - Product Code MEC
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.
Code Information Software versions up to and including 1.5.1.
Recalling Firm/
Manufacturer		 Getinge Disinfection Ab
Ljungadalsgatan 11
Vaxjo Sweden
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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