The FDA voluntary recalled Fujifilm's ED-530XT duodenoscopes.
Here's what you should know:
1. The FDA has notified all customers of the voluntary recall. Fujifilm will replace the ED-530XT's forceps elevator mechanism. The full replacement includes the O-ring seal and the distal end cap. Fujifilm updated the device's operations manual as well.
2. Fujifilm previously revised the ED-530XT duodenoscope's reprocessing instructions in December 2015, to replace the ones originally included with the device. The FDA recommends facilities still use these validated instructions for reprocessing.
3. The FDA encourages centers to use Fujifilm's Urgent Medical Device Correction and Removal letter to identify affected products in the facility. The agency also advises removing all outdated operation manuals after receipt of the updated manual.
4. The FDA will continue to monitor the issue moving forward.