Recall Z-1860-2016— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-1860-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-23

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2015-12-23, terminated 2018-01-18. It names one FDA 510(k) clearance: K042076. Product: Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'. Reason: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures..

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Terminated: 2018-01-18
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K042076 — FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5Fujinon, Inc.·cleared 2004-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'

Reason for recall

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Data sourced from openFDA. This site is unofficial and independent of the FDA.