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Terminated

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

FDA Recall Z-2706-2017 · Posted None

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeFDS
Date Initiated2017-02-17
Date Terminated2018-10-03
Product Quantity4 units

Reason for Recall

Fujifilm is recalling multiple endoscopes after a retrospective review.

Firm Action

Fujifilm sent an Urgent - Medical Device Removal letter dated February 17, 2017. Customers are provided information regarding the recall and asked to complete the attached form and return to Fujifilm. Questions can be directed to sales representative. For further questions, please call (973) 709-2202.

Root Cause

Other

Distribution Pattern

US Distribution to : AL, HI and MO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063847FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700Fujinon, Inc. · 2007-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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