Boston Scientific recalls EXALT Controller devices with potential darker image settings for endoscopic procedures. Affected units have specific serial numbers and were sold with endoscopes for diagnosis.
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Boston Scientific is recalling EXALT Controller devices that may display images too dark for endoscopic procedures. This could affect image clarity during medical diagnoses and treatments.
The EXALT Controller may have been programmed with a brightness setting that produces darker images than intended. This could reduce image clarity during endoscopic procedures, potentially affecting diagnosis or treatment decisions.
Medical professionals using the EXALT Controller with endoscopes for diagnosis or treatment are most likely affected. Patients receiving these procedures may be at risk if image clarity is compromised.
Check for serial numbers 2005201213, 2005201287, or 2005201346 on the EXALT Controller. These devices were sold with Boston Scientific endoscopes for medical procedures.
Look for serial numbers 2005201213, 2005201287, or 2005201346 on the EXALT Controller.
The EXALT Controller may have been programmed with a brightness setting that produces darker images than intended, potentially reducing image clarity during endoscopic procedures.
Check for serial numbers 2005201213, 2005201287, or 2005201346 on the device. These specific serial numbers are affected.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1492-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1492-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
