News | Endoscopes | August 03, 2017

Fujifilm Issues Voluntary Recall of All ED-530XT Duodenoscopes

July recall based on February 2015 FDA Safety Communication indicating complex design of duodenoscopes may impede effective reprocessing

Fujifilm Issues Voluntary Recall of All ED-530XT Duodenoscopes

August 3, 2017 — On July 21, 2017, Fujifilm issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes. This action includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The U.S. Food and Drug Administration (FDA) cleared the updated design and labeling for the ED-530XT on July 21, 2017.

As noted in FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.

The recommendations include:

  • Acknowledge Fujifilm's Urgent Medical Device Correction and Removal and identify affected products in your facility.
    • Indicate if you do not have any affected duodenoscopes or Operation Manuals;
    • Upon receipt of the enclosed new Operation Manuals, remove and replace any older operation manuals from your facility, and destroy and dispose of properly.
  • Be aware of the manual reprocessing procedures outlined in FDA's December 23, 2015 Safety Communication "Fujifilm Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes."
    • Continue to use these validated instructions when reprocessing Fujifilm ED-530XT duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Fujifilm ED-530XT duodenoscope.

FDA's recommendations are based on currently available information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the full Safety Communication.

For more information: www.fda.gov

Related Content

Body Vision Medical Announces Release of LungVision
Technology | Lung Cancer | October 05, 2018
Body Vision Medical, a medical device company specializing in lung cancer diagnostics, announced the launch of its...
American Society for Gastrointestinal Endoscopy and Touch Surgery Pilot Video-Based Endoscopic Simulations
News | Endoscopes | June 11, 2018
During the 2018 Digestive Disease Week (DDW) conference June 2-5 in Washington, D.C., the American Society for...
Olympus and Hitachi Healthcare Americas Introduce Arietta 850
News | Ultrasound Imaging | June 04, 2018
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedu
Body Vision Medical Receives FDA Clearance for LungVision Tool
Technology | Lung Cancer | May 09, 2018
Body Vision Medical received clearance from the U.S. Food and Drug Administration (FDA) to market their LungVision Tool...
El Camino Hospital Performs First U.S. Robotic Lung Cancer Bronchoscopy
News | Oncology Diagnostics | April 25, 2018
The interventional pulmonology team at the Taft Center for Clinical Research at El Camino Hospital in Mountain View,...
News | Endoscopes | April 02, 2018
Results from a recent prospective trial found the Wide Area Transepithelial Sampling with 3D Tissue Analysis (WATS3D)...
Auris Health Unveils FDA-Cleared Monarch Platform for Robotic Bronchoscopy
Technology | Endoscopes | March 26, 2018
March 26, 2018 — Auris Health Inc. announced U.S.
FDA, CDC and ASM Release New Duodenoscope Surveillance and Culturing Protocols
News | Endoscopes | February 26, 2018
The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for...
Dilon Technologies Inc. Launches New CoPilot VL+ Video Laryngoscope
Technology | Endoscopes | February 07, 2018
February 7, 2018 — Dilon Technologies Inc.
CapsoVision Inc. Introduces CapsoCloud for CapsoCam Plus Endoscopy System
Technology | Endoscopes | September 14, 2017
CapsoVision Inc. recently announced the full U.S. launch of CapsoCloud, an exam management system that allows...