FDAClass IIIMay 5, 2021

EXALT Controller - Product Usage: intended for use with recall

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN…

Why was EXALT Controller - Product Usage: intended for use with recalled?

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

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?

Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901

Product
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN…
Recalling firm
Boston Scientific Corporation
Quantity
3 units
Distribution
US Nationwide distribution in the states of CA, FL, NJ.
Recall date
May 5, 2021
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls