2017-07-24 19:17:54 UTC

Device Recall: Fujifilm ED-530XT Duodenoscopes

July 24, 2017

If you use this device, Fujifilm will be in touch by October 2017 with next steps for replacing your device(s).

FUJIFILM Medical Systems, U.S.A., Inc. has issued a voluntary recall for its model ED-530XT duodenoscopes after the FDA approved updated design and labelling for the device. For more information, please review the FDA Safety Communication

During this recall, Fuijifilm will be replacing the ED-530XT forceps elevator mechanism including the O-ring seal and replacement of the distal end cap. The company will also be issuing new Operation Manuals — upon receipt of the new Operation Manuals, remove and replace any older manuals from your facility.

This recall is in response to FDA’s 2015 call to device manufacturers to modify and validate their device designs and reprocessing instructions to eliminate the risk of transmission of infectious agents through duodenoscopes.

The AGA Center for GI Innovation and Technology is committed to working towards zero device-associated infections and will keep you apprised of any future updates.

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