Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1492-2021 — EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

U.S. FDA — Device Enforcement · United States · 2021-03-16 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1492-2021
Date of alert
2021-03-16
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2005201213
Reported risk: May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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