FDA recall Z-3129-2017

Product

Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 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.

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2015-03-09

Report date

2017-09-20

Termination date

2018-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3129-2017