FDA Device

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

Hazard

Fujifilm is recalling multiple endoscopes after a retrospective review.

What You Should Do

Remedy

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.

Products

Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
Brand
Fujifilm Medical Systems U.S.A., Inc.
UPC
1U881A131 1U88A1A145 3U881A005

Units Affected

4 units