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Open, Classified

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.

FDA Recall Z-1734-2024 · Posted 2024-05-01

Recalling FirmNoah Medical
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2024-03-09
Product Quantity17 wired controllers

Reason for Recall

Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

Firm Action

On 03/09-11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx overnight to customers informing them that due to an misalignment calibration of wired controller, it potentially could cause unintended motion of the Galaxy bronchoscope. Customers are instructed to: -Not utilize any of the wired controllers -Remove from service -Return to Noah Medical For any questions, contact Customer Service at 888-325-6624, ext. 3

Root Cause

Process control

Distribution Pattern

U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223144Galaxy SystemNoah Medical Corp. · 2023-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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