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

Recall Z-1734-2024 — Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

U.S. FDA — Device Enforcement · United States · 2024-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1734-2024
Date of alert
2024-03-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Noah Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850048825048
Reported risk: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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