Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2017 - (Recall #: Z-3225-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Product Classification:

Class II

Date Initiated: July 21, 2017

Date Posted: October 4, 2017

Recall Number: Z-3225-2017

Event ID: 78065

Reason for Recall:

An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.

Status: Terminated

Product Quantity: 362 units

Code Information:

All lots/serial numbers

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated