Fujifilm Medical (TSE:4901) today issued a select voluntary recall for its model ED-530XT duodenoscopes after the FDA cleared an update to the design and labeling of the device, intending to supply customers with new forceps elevator mechanism from Platform Lift, O-ring seals, distal end caps and updated operations manuals.
The company said it won FDA clearance for the updated design and labeling today, with the intention of implanting them to reduce potential health risks during reprocessing of the device.
Duodenoscopes have been linked in the past to superbug outbreaks, with the FDA issuing specific warnings in an attempt to curb such infections.
The ED-530XT duodenoscope is a medical endoscope designed for visualizing the duodenum and the upper digestive track for observing, diagnosing and treating the esophagus, stomach and duodenum, FujiFilm Medical said.
The company said it will contact all its customers by October with details on returning the devices for replacement parts, and instructed customers with the devices to replace all manuals with new versions.
FujiFilm said the process of returning and replacing the devices would take approximately 2 weeks, and that it would supply duodenoscopes in the interim.
In January, FujiFilm said it was pulling its legacy 250/450 duodenoscope models from clinical use and replace those devices with the ED-530XT model at no cost to its customers.
The company said in a letter to its customers that the decision is not directly related to any safety concerns and that it has not received any recent reports of adverse events associated with the scopes.