FDAClass IISeptember 28, 2016

Pentax Video Bronchoscope Designed to be used with a recall

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor…

Why was Pentax Video Bronchoscope Designed to be used with a recalled?

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect 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-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K

Product
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor…
Recalling firm
Pentax of America Inc
Quantity
1719 units
Distribution
Nationwide Distribution
Recall date
September 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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