Fujifilm recalls ED-530XT endoscopes for design flaws

The FDA announced that Fujifilm has issued a voluntary recall of its ED-530XT duodenoscopes used in endoscopic retrograde cholangiopancreatography, or ERCP, procedures.

The company has sent an Urgent Medical Device Correction and Removal notification to customers, and will replace the device’s forceps elevator mechanism including the O-ring seal, as well as its distal end cap and a new operation manual, according to the FDA safety communication. The FDA has approved the updated design and labeling for the ED-530XT model.

The FDA has been working with manufacturers to address effective reprocessing of duodenoscopes following a safety communication in February 2015, which alerted customers that the complex design of the scopes could impede effective cleaning and disinfection. This was prompted by the high profile “superbug” outbreaks linked to duodenoscopes that same year.

The FDA recommends that customers acknowledge receipt of Fujifilm’s Urgent Medical Device Correction and Removal notification, identify any affected products in their facility, and indicate if they do not have any affected duodenoscopes.

Reference:

FDA. ED-530XT Duodenoscopes by Fujifilm: Safety Communication - Recall Issued, Updated Design and Labeling. July 21, 2017. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm567793.htm