Fujifilm Medical Systems U.S.A., Inc. recalls Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'

Recalled June 8, 2016 · FDA recall Z-1860-2016 · Fujifilm Medical Systems U.S.A

Hazard

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

Units

1473 units

Sold at

Nationwide Distribution.

Description

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

Product

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

Manufacturer(s)

Fujifilm Medical Systems U.S.A., Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →