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Recall Observatory FDA recall evidence

Device product

Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

Z-2706-2017

February 17, 2017

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 76899
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-2706-2017

Official wording

Reason: Fujifilm is recalling multiple endoscopes after a retrospective review.

Code information: 1U881A131 1U88A1A145 3U881A005

Distribution pattern: US Distribution to : AL, HI and MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Fujifilm is recalling multiple endoscopes after a retrospective review.