FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
- Recall number
- Z-1492-2021
- 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
- Status
- Terminated
- Initiated
- 2021-03-16
- Posted
- not on file
- Terminated
- 2022-05-02
- Reason
- May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
- 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 BSCFieldActionCenter@bsci.com or fax to 763-415-7708.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of CA, FL, NJ.
- Lot, serial or model codes
- Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDT
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28