FDAClass IIIAugust 26, 2015

Getinge 86 Series Washer/Disinfector with G1 control recall

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

Why was Getinge 86 Series Washer/Disinfector with G1 control recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software versions up to and including 1.5.1.

Product
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories…
Recalling firm
Getinge Disinfection Ab
Quantity
20 devices
Distribution
Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.
Recall date
August 26, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls