EXALT recallZ-1492-2021 · Boston Scientific Corporation · initiated Mar 16, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1492-2021
- Status
- Terminated
- Initiated by the company
- Mar 16, 2021
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 3 units
- Product code
- FDT
- Distribution
- US Nationwide distribution in the states of CA, FL, NJ.
Product description
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Code information (models, lots, serial numbers)
Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EXALT™ M00542430Boston Scientific Corporation · Endoscopic video imaging system/component, gastroenterology-urology1 recall38 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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