FDA recall Z-3128-2017

Fujifilm Medical Systems U.S.A., Inc. · Class II · device

Product

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.

Reason for recall

Fujifilm is reporting 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-3128-2017