FDAClass IIDecember 21, 2016

Ultrasound Video Bronchoscope The EB-1970UK recall

Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization…

Why was Ultrasound Video Bronchoscope The EB-1970UK recalled?

The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.

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?

EB-1970UK

Product
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization…
Recalling firm
Pentax of America Inc
Quantity
113 units
Distribution
Nationwide Distribution
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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