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Open, Classified

Galaxy System (GAL-001)

FDA Recall Z-0693-2025 · Posted 2024-12-18

Recalling FirmNoah Medical
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2024-10-25
Product Quantity26

Reason for Recall

Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

Firm Action

On 10/25/24, the firm started hand delivering correction notices to customers informing them of the following: If your device is affected the firm will contact you to inspect and if necessary to replace the power supply. Firm contact: [email protected], 1-888-325-6624

Root Cause

Device Design

Distribution Pattern

US: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY

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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