Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2017 - (Recall #: Z-3128-2017)

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:

Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

Product Classification:

Class II

Date Initiated: March 9, 2015

Date Posted: September 20, 2017

Recall Number: Z-3128-2017

Event ID: 76905

Reason for Recall:

Fujifilm is reporting a corrective action due to an FDA inspection.

Status: Terminated

Product Quantity: 260 manuals in total

Code Information:

For Manual Code 202B1259902B, 140417-3.0-DT-US2 - 157 manuals were distributed For Manual Code 202B1237697D, 140408-5.0-DT-US2 - 103 manuals were distributed

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated