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U.S. Department of Health and Human Services

Class 2 Device Recall Galaxy System

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 Class 2 Device Recall Galaxy Systemsee related information
Date Initiated by FirmOctober 25, 2024
Date PostedDecember 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0693-2025
Recall Event ID 95712
510(K)NumberK223144 
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductGalaxy System (GAL-001)
Code Information UDI-DI: 00850048825048. Serial Numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB-1540, CRB-1541, CRB-1543, CRB-1554
Recalling Firm/
Manufacturer		 Noah Medical
1501 Industrial Rd
San Carlos CA 94070-4111
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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: customerservice@noahmed.com, 1-888-325-6624
Quantity in Commerce26
DistributionUS: CA, MA, PA, NJ, ID, CT, MO, NC, MD, IL, TN, VA, OH, IN, WV, NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EOQ
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