The company issued the recall after receiving regulatory approval for an updated design and device label intended to reduce infection risk. The updated design requires several replacement parts — including a new distal end cap and forceps elevator mechanism — along with a new operations manual.
Fujifilm will contact all customers using the recalled device and send instructions for how to receive the replacement parts by October.
In January, the FDA issued a safety alert stating Fujifilm Medical Systems planned to remove four duodenoscope legacy models from clinical use. The retired models were set to be replaced with the ED-530XT.
To learn more about the recall, click here.
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