Recall Z-0693-2025— Noah Medical
Class II · Ongoing
Class II FDA medical device recall by Noah Medical, initiated 2024-10-25. It names one FDA 510(k) clearance: K223144. Product: Galaxy System (GAL-001). Reason: 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..
- Recalling firm
- Noah Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-25
- Firm location
- San Carlos, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Galaxy System (GAL-001)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.