Z-1492-2021Class III

EXALT Controller -

Name: Z-1492-2021 EXALT Controller -
Creator: Boston Scientific Corporation
Published: 2021-03-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-03-16 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 on 2021-03-16. FDA classified it as Class III and gives the reason as "May have been programmed with a less than optimal brightness setting resulting in a darker than desired image". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1492-2021
Classification: Class III
Status: Terminated
Initiated: 2021-03-16
Posted: 2021-04-26
Terminated: 2022-05-02
Recalling firm: Boston Scientific Corporation
Product: EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued Medical Device Removal - Immediate Action Required letter on 3/16/21. Letter states reason for recall, health risk and action to take: While no adverse health consequences are anticipated and an impacted Controller can continue to be used, replacement of the Controller is advised for optimal image quality. A Boston Scientific representative will be in contact with you directly to schedule installation of a replacement Controller at your facility. If you notice a darker than desired image, manually adjust the brightness setting on the front of the EXALT" Controller to the High setting (all five bars on the Brightness Indicator illuminated) A Boston Scientific representative will be in contact with you directly to schedule the installation of a replacement Controller at your facility. Your current Controller will be removed at that time. Please read carefully through the enclosed instructions. We ask that you please confirm receipt of this notification by completing the enclosed Acknowledgement Form and sending it to [email protected] or fax to 763-415-7708.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of CA, FL, NJ.
Product codes and lots: Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1492-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1492-2021	Class III	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-26

Product code FDT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)