FDAClass IIJuly 19, 2017

Ultrasonic Endoscope recall

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

Why was Ultrasonic Endoscope recalled?

Fujifilm is recalling multiple endoscopes after a retrospective review.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1U881A131 1U88A1A145 3U881A005

Product
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
Recalling firm
Fujifilm Medical Systems U.S.A., Inc.
Quantity
4 units
Distribution
US Distribution to : AL, HI and MO
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls